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Assessing the Effect of a Mineral-enriched Powder on Iron Deficiency in Women of Reproductive Age

Primary Purpose

Iron Deficiency, Iron Deficiency Anaemia

Status
Recruiting
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Mineral-enriched powder
Placebo powder
Sponsored by
Carleton University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Iron Deficiency focused on measuring Iron deficiency, Iron deficiency anaemia, Iron fortification, Reproductive-aged women

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Non-pregnant and non-lactating English speaking with the ability to give informed consent 18-35 years of age (inclusive) Women who are biologically female Iron deficient (SF >/=12μg/L and </=20 μg/L). Note: there is currently poor consensus on diagnostic criteria for iron deficiency based on SF concentrations. Current recommendations range from 15 μg/L to 100 μg/L. Hb >/=110 g/L Willing and able to agree to the requirements and lifestyle restrictions of this study Able to understand and read the questionnaires in English and carry out all study-related procedures Located in the greater Ottawa area and a resident of Ontario Exclusion Criteria: Individuals who are lactating, pregnant, or planning to become pregnant during the study Individuals who are not maintaining adequate birth control measures Adequate birth control measures include any option that will adequately prevent pregnancy including: contraceptives, lifestyle choices, complete abstinence, or as a result of other medical methods, procedures, or conditions Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients Are using vitamin and mineral supplements containing iron and/or zinc SF concentrations <12 μg/L or >20 μg/L Having moderate or severe anaemia (Hb <109 g/L) Expecting to change diet and exercise regimen in the next 6 months Are frequent blood donors Have donated blood in the last four months Donate blood more than two to three times per year Had major surgery in the past three months Have planned surgery during the course of the study History of problematic alcohol or substance use in the 12 months prior to screening (including having been hospitalized for such in an in-patient or out-patient intervention program) Use of investigational product(s) in another research study within 30 days prior to the baseline visit or during the study duration Using any of the following drugs: Antacids or proton pump inhibitors, H2 blockers Salicylates, aspirin, corticosteroids, nonsteroidal anti-inflammatory drugs Anticoagulants, antiplatelet compounds Drugs with known contraindication with iron supplementation or fortification Antiviral medications Levothyroxine (Synthroid) Known medical history of specific conditions including: Gastrointestinal disorders: celiac disease, ulcerative colitis, and Crohn's disease Gastric cancer and gastric polyps Colon cancer Diverticular bleeding Inflammatory bowel diseases Angiodysplasia Helicobacter pylori infection Hookworm (Ancylostoma duodenale and Necator americanus) Defects of hemostasis (hereditary hemorrhagic telangectasia, von Willebrand disease) Gastrectomy, duodenal bypass, bariatric surgery Erythropoiesis-stimulating agent therapy Chronic kidney disease Hemochromatosis Hemoglobinopathies Blood clotting disorder Have any other active or unstable medical conditions or use of medications/supplements/ therapies that according to the scientific literature, may adversely affect the participant's ability to complete the study or its measures or pose a significant risk to the participant or the quality of the study data.

Sites / Locations

  • Carleton UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active intervention

Placebo

Arm Description

Mineral-enriched powder

Placebo powder

Outcomes

Primary Outcome Measures

Serum ferritin (SF) concentrations between active intervention and placebo groups at endline (six months). Proportion of participants remaining iron deficient between active intervention and placebo groups at six months.
SF concentrations will be measured using standard clinical lab assay.

Secondary Outcome Measures

Change in SF concentrations from enrolment (baseline), to midline (three months), and endline (six months).
SF concentrations will be measured using standard clinical lab assay.
Change in haemoglobin (Hb) concentrations from enrolment (baseline), to midline (three months), and endline (six months).
Hb concentrations will be measured using standard clinical lab assay.
Levels of metabolites (circulating metabolome) at baseline, three months, and six months.
Functional metabolites in plasma will be measured by Liquid Chromatography-Mass Spectrometry (LC-MS) and Inductively Coupled Plasma-Mass Spectrometry (ICP-MS).
Concentrations of key circulating pro-inflammatory biomarkers at baseline, three months, and six months.
Plasma pro-inflammatory biomarkers will be measured using standard protocols via multi-plex assay (Human Cytokine 27-plex Assay, BioRad) which includes biomarkers such as TNF-alpha, IL-6, MCP-1. The assay will be conducted, and biomarkers measured according to manufacturer's guidelines.
Dietary recall: proportion of participants meeting dietary reference intakes at baseline, three months, and six months.
Mean food and nutrient intakes will be used to determine proportion of participants meeting dietary reference intakes. Dietary recalls will be conducted using the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24) Canada 2018. This tool measures all food and beverages consumed over a 24-hour period. Dietary recalls will be considered complete if participants provide a minimum of two days of 24-hour recall.
Dietary recall: dietary patterns at baseline, three months, and six months.
Mean food and nutrient intakes will be used to determine dietary patterns of foods known to alter iron absorption.
Dietary recall: Healthy Eating Index (HEI) at baseline, three months, and six months.
Mean food and nutrient intakes will be used to determine HEI scores.
Dietary recall: Dietary Inflammatory Index (DII) at baseline, three months, and six months.
Mean food and nutrient intakes will be used to determine DII scores.
Self-reported perceptions of health at baseline and six months.
Proportion of participants reporting overall good health status will be measured at baseline and at six months. A descriptive health profile will be generated based on health dimensions in both the active intervention and placebo groups. Number of patients, proportions of categorical responses for each health dimensions, including the severity of the health concern will be derived. The investigators will explore significance of change in health profile within each group and significance of the difference between the active intervention and placebo groups at six months. The investigators will assess associations of health profile with adherence to study regimen.
Feasibility: Adherence to the consumption regimen for the regular use of the powder.
Proportion of participants with >80% adherence (defined as preparation and consumption of the powder on at least 4 days per week or a minimum of every second day for the duration of the trial) will be measured bi-weekly for the duration of the trial. Adherence will be determined using the study diary, in which participants will report which days they consumed the study product and which days they did not. Adherence will be reported by participants bi-weekly for the duration of the study.
Feasibility: Adherence to the consumption regimen for the regular use of the powder at three months and six months.
Proportion of unused powder sachets will be measured at three and six months. Participants will be asked to return all used (opened) and unused (unopened) powder sachets at three months and six months. Proportion of unused sachets will be calculated.
Feasibility: Self-reported barriers to use of the powder.
Proportion of participants reporting perceived barriers to use of the study product at six months. Qualitative summary of types of perceived barriers at six months.
Palatability.
Palatability (i.e. odour, colour, and taste assessments) collected at six months. Palatability assessments of the study product will be conducted at six months using a 9-point hedonic scale to generate palatability scores (where >/=5 indicates that the solution was liked). Differences in participant palatability scores (for colour, odour, sweet, sour, bitter, salty, umami and overall liking) and proportion of participants willing to drink the sample daily will be used to assess the palatability of the powder, show whether the powder is accepted by consumers, and document relationships between palatability and adherence.
Economic: Overall health status.
Overall health status will be measured by the EuroQol-5D visual analogue scale (EQ-5D VAS) at six months. The EQ-5D VAS provides a score of 0 to 100, where 0 represents the worst imaginable health status and 100 represents the best imaginable health status.
Economic: Health state/health state index.
Health state values will be measure by EuroQol-5D (EQ-5D) at six months. Health state values will be used to generate health state index score using Canadian valuation of EQ-5D health states.
Economic: Quality adjusted life years (QALYs).
Health state index scores derived from the EuroQol-5D (EQ-5D) at six months will be used to calculate quality-adjusted life years (QALYs), which will be used to perform cost effectiveness analysis.
Safety (adverse events/harms).
Proportion of adverse events (AEs) and proportion of withdrawals from the study due to harms will be measured at baseline, three months, six months, and approximately seven months (four weeks post study end). AE/harms monitoring will occur bi-weekly for the duration of the study and up to four weeks after last study visit for unresolved AEs.

Full Information

First Posted
May 26, 2023
Last Updated
August 10, 2023
Sponsor
Carleton University
Collaborators
University of Ottawa, Hopital Montfort, Lucky Iron Fish Enterprise
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1. Study Identification

Unique Protocol Identification Number
NCT05990166
Brief Title
Assessing the Effect of a Mineral-enriched Powder on Iron Deficiency in Women of Reproductive Age
Official Title
Randomised Controlled Trial to Assess the Effect of a Mineral-enriched Powder on Iron Deficiency in Women of Reproductive Age
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 27, 2023 (Actual)
Primary Completion Date
April 2, 2024 (Anticipated)
Study Completion Date
May 2, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Carleton University
Collaborators
University of Ottawa, Hopital Montfort, Lucky Iron Fish Enterprise

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
The goal of this clinical trial is to determine if taking a mineral-enriched powder can raise blood iron levels compared to a placebo powder in reproductive-aged women with iron deficiency. The main questions it aims to answer are: Does the mineral-enriched powder raise blood iron levels compared to a placebo powder in women when it is taken every day for six months? How many participants still have iron deficiency after six months of taking the mineral-enriched powder compared to a placebo powder? Participants in this clinical trial will drink the mineral-enriched powder containing ferrous iron and zinc sulphate monohydrate or a placebo powder mixed with 1 litre of water daily for six months. The placebo is a look-alike substance that does not contain active ingredients (iron and zinc). Participants will also have to: Complete an online "study diary" every two weeks for six months Provide a blood sample once a month for six months Attend three in-person visits with a researcher, at enrolment (baseline), midline (three months), and endline (six months) Complete three sets of online questionnaires (following each in-person visit) Complete three sets of dietary assessments (following each in-person visit) Provide three stool samples (following each in-person visit)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency, Iron Deficiency Anaemia
Keywords
Iron deficiency, Iron deficiency anaemia, Iron fortification, Reproductive-aged women

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Double-blind randomised placebo-controlled trial
Masking
ParticipantInvestigator
Masking Description
All participants, researchers, and the study physician will be blinded to the treatment group (active intervention or placebo) to which participants have been randomised. A delegated unblinded staff member will be permitted to unblind participants for safety purposes, if requested by the principal investigators or the study physician.
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active intervention
Arm Type
Experimental
Arm Description
Mineral-enriched powder
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo powder
Intervention Type
Other
Intervention Name(s)
Mineral-enriched powder
Intervention Description
Mineral-enriched powder Mineral-enriched powder to allow for at-home fortification of beverages with 5 mg of ferrous iron and 10 mg of zinc sulfate monohydrate
Intervention Type
Other
Intervention Name(s)
Placebo powder
Intervention Description
Placebo powder which is identical to the mineral- enriched powder, but does not contain the active ingredients (ferrous iron and zinc sulfate monohydrate)
Primary Outcome Measure Information:
Title
Serum ferritin (SF) concentrations between active intervention and placebo groups at endline (six months). Proportion of participants remaining iron deficient between active intervention and placebo groups at six months.
Description
SF concentrations will be measured using standard clinical lab assay.
Time Frame
Six months
Secondary Outcome Measure Information:
Title
Change in SF concentrations from enrolment (baseline), to midline (three months), and endline (six months).
Description
SF concentrations will be measured using standard clinical lab assay.
Time Frame
Baseline, three months, six months
Title
Change in haemoglobin (Hb) concentrations from enrolment (baseline), to midline (three months), and endline (six months).
Description
Hb concentrations will be measured using standard clinical lab assay.
Time Frame
Baseline, three months, six months
Title
Levels of metabolites (circulating metabolome) at baseline, three months, and six months.
Description
Functional metabolites in plasma will be measured by Liquid Chromatography-Mass Spectrometry (LC-MS) and Inductively Coupled Plasma-Mass Spectrometry (ICP-MS).
Time Frame
Baseline, three months, six months
Title
Concentrations of key circulating pro-inflammatory biomarkers at baseline, three months, and six months.
Description
Plasma pro-inflammatory biomarkers will be measured using standard protocols via multi-plex assay (Human Cytokine 27-plex Assay, BioRad) which includes biomarkers such as TNF-alpha, IL-6, MCP-1. The assay will be conducted, and biomarkers measured according to manufacturer's guidelines.
Time Frame
Baseline, three months, six months
Title
Dietary recall: proportion of participants meeting dietary reference intakes at baseline, three months, and six months.
Description
Mean food and nutrient intakes will be used to determine proportion of participants meeting dietary reference intakes. Dietary recalls will be conducted using the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24) Canada 2018. This tool measures all food and beverages consumed over a 24-hour period. Dietary recalls will be considered complete if participants provide a minimum of two days of 24-hour recall.
Time Frame
Baseline, three months, six months
Title
Dietary recall: dietary patterns at baseline, three months, and six months.
Description
Mean food and nutrient intakes will be used to determine dietary patterns of foods known to alter iron absorption.
Time Frame
Baseline, three months, six months
Title
Dietary recall: Healthy Eating Index (HEI) at baseline, three months, and six months.
Description
Mean food and nutrient intakes will be used to determine HEI scores.
Time Frame
Baseline, three months, six months
Title
Dietary recall: Dietary Inflammatory Index (DII) at baseline, three months, and six months.
Description
Mean food and nutrient intakes will be used to determine DII scores.
Time Frame
Baseline, three months, six months
Title
Self-reported perceptions of health at baseline and six months.
Description
Proportion of participants reporting overall good health status will be measured at baseline and at six months. A descriptive health profile will be generated based on health dimensions in both the active intervention and placebo groups. Number of patients, proportions of categorical responses for each health dimensions, including the severity of the health concern will be derived. The investigators will explore significance of change in health profile within each group and significance of the difference between the active intervention and placebo groups at six months. The investigators will assess associations of health profile with adherence to study regimen.
Time Frame
Baseline, six months
Title
Feasibility: Adherence to the consumption regimen for the regular use of the powder.
Description
Proportion of participants with >80% adherence (defined as preparation and consumption of the powder on at least 4 days per week or a minimum of every second day for the duration of the trial) will be measured bi-weekly for the duration of the trial. Adherence will be determined using the study diary, in which participants will report which days they consumed the study product and which days they did not. Adherence will be reported by participants bi-weekly for the duration of the study.
Time Frame
Bi-weekly through study completion, approximately 7 months
Title
Feasibility: Adherence to the consumption regimen for the regular use of the powder at three months and six months.
Description
Proportion of unused powder sachets will be measured at three and six months. Participants will be asked to return all used (opened) and unused (unopened) powder sachets at three months and six months. Proportion of unused sachets will be calculated.
Time Frame
Baseline, three months, six months
Title
Feasibility: Self-reported barriers to use of the powder.
Description
Proportion of participants reporting perceived barriers to use of the study product at six months. Qualitative summary of types of perceived barriers at six months.
Time Frame
Six months
Title
Palatability.
Description
Palatability (i.e. odour, colour, and taste assessments) collected at six months. Palatability assessments of the study product will be conducted at six months using a 9-point hedonic scale to generate palatability scores (where >/=5 indicates that the solution was liked). Differences in participant palatability scores (for colour, odour, sweet, sour, bitter, salty, umami and overall liking) and proportion of participants willing to drink the sample daily will be used to assess the palatability of the powder, show whether the powder is accepted by consumers, and document relationships between palatability and adherence.
Time Frame
Six months
Title
Economic: Overall health status.
Description
Overall health status will be measured by the EuroQol-5D visual analogue scale (EQ-5D VAS) at six months. The EQ-5D VAS provides a score of 0 to 100, where 0 represents the worst imaginable health status and 100 represents the best imaginable health status.
Time Frame
Six months
Title
Economic: Health state/health state index.
Description
Health state values will be measure by EuroQol-5D (EQ-5D) at six months. Health state values will be used to generate health state index score using Canadian valuation of EQ-5D health states.
Time Frame
Six months
Title
Economic: Quality adjusted life years (QALYs).
Description
Health state index scores derived from the EuroQol-5D (EQ-5D) at six months will be used to calculate quality-adjusted life years (QALYs), which will be used to perform cost effectiveness analysis.
Time Frame
Six months
Title
Safety (adverse events/harms).
Description
Proportion of adverse events (AEs) and proportion of withdrawals from the study due to harms will be measured at baseline, three months, six months, and approximately seven months (four weeks post study end). AE/harms monitoring will occur bi-weekly for the duration of the study and up to four weeks after last study visit for unresolved AEs.
Time Frame
Baseline, three months, six months, and seven months
Other Pre-specified Outcome Measures:
Title
Exploratory: Microbial metagenome.
Description
The gut microbial metagenome at baseline, three months, and six months. Bacterial genomic DNA will be isolated from stool samples and analysed by whole genome sequencing. Outcomes will be reported descriptively in placebo and intervention groups for: relative abundance, diversity, and variance.
Time Frame
Baseline, three months, six months
Title
20. Exploratory: Microbial metagenome inferred function.
Description
Exploratory analyses of inferred function of the metagenome at baseline, three months, and six months. Compositional approaches and Ingenuity Pathway Analysis will be used to generate hypotheses of genes, networks and biological pathways and processes that may be influenced by the intervention, accounting for clinical data.
Time Frame
Baseline, three months, six months
Title
Exploratory: Microbial metabolome.
Description
The gut metabolome at baseline, three months, and six months. Microbial metabolome will be measured in placebo and intervention groups and data related to computationally-derived functions from metagenome data) using Liquid Chromatography-Mass Spectrometry (LC-MS) and Inductively Coupled Plasma-Mass Spectrometry (ICP-MS). Data will be processed under standard pipelines with visualisation and pathway analysis by Agilent Mass Profiler, MetaboAnalyst and KEGG databases.
Time Frame
Baseline, three months, six months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Non-pregnant and non-lactating English speaking with the ability to give informed consent 18-35 years of age (inclusive) Women who are biologically female Iron deficient (SF >/=12μg/L and </=20 μg/L). Note: there is currently poor consensus on diagnostic criteria for iron deficiency based on SF concentrations. Current recommendations range from 15 μg/L to 100 μg/L. Hb >/=110 g/L Willing and able to agree to the requirements and lifestyle restrictions of this study Able to understand and read the questionnaires in English and carry out all study-related procedures Located in the greater Ottawa area and a resident of Ontario Exclusion Criteria: Individuals who are lactating, pregnant, or planning to become pregnant during the study Individuals who are not maintaining adequate birth control measures Adequate birth control measures include any option that will adequately prevent pregnancy including: contraceptives, lifestyle choices, complete abstinence, or as a result of other medical methods, procedures, or conditions Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients Are using vitamin and mineral supplements containing iron and/or zinc SF concentrations <12 μg/L or >20 μg/L Having moderate or severe anaemia (Hb <109 g/L) Expecting to change diet and exercise regimen in the next 6 months Are frequent blood donors Have donated blood in the last four months Donate blood more than two to three times per year Had major surgery in the past three months Have planned surgery during the course of the study History of problematic alcohol or substance use in the 12 months prior to screening (including having been hospitalized for such in an in-patient or out-patient intervention program) Use of investigational product(s) in another research study within 30 days prior to the baseline visit or during the study duration Using any of the following drugs: Antacids or proton pump inhibitors, H2 blockers Salicylates, aspirin, corticosteroids, nonsteroidal anti-inflammatory drugs Anticoagulants, antiplatelet compounds Drugs with known contraindication with iron supplementation or fortification Antiviral medications Levothyroxine (Synthroid) Known medical history of specific conditions including: Gastrointestinal disorders: celiac disease, ulcerative colitis, and Crohn's disease Gastric cancer and gastric polyps Colon cancer Diverticular bleeding Inflammatory bowel diseases Angiodysplasia Helicobacter pylori infection Hookworm (Ancylostoma duodenale and Necator americanus) Defects of hemostasis (hereditary hemorrhagic telangectasia, von Willebrand disease) Gastrectomy, duodenal bypass, bariatric surgery Erythropoiesis-stimulating agent therapy Chronic kidney disease Hemochromatosis Hemoglobinopathies Blood clotting disorder Have any other active or unstable medical conditions or use of medications/supplements/ therapies that according to the scientific literature, may adversely affect the participant's ability to complete the study or its measures or pose a significant risk to the participant or the quality of the study data.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristin Connor, PhD
Phone
613-520-2600
Ext
4202
Email
kristin.connor@carleton.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Bénédicte Fontaine-Bisson, RD, PhD
Phone
613-562-5800
Ext
8432
Email
bfontain@uOttawa.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin Connor, PhD
Organizational Affiliation
Carleton University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bénédicte Fontaine-Bisson, RD, PhD
Organizational Affiliation
University of Ottawa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carleton University
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1S 5B6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristin Connor, PhD
Phone
613-520-2600
Ext
4202
Email
kristin.connor@carleton.ca
First Name & Middle Initial & Last Name & Degree
Bénédicte Fontaine-Bisson, RD, PhD
Phone
613-562-5800
Ext
8432
Email
bfontain@uOttawa.ca
First Name & Middle Initial & Last Name & Degree
Kristin Connor, PhD
First Name & Middle Initial & Last Name & Degree
Bénédicte Fontaine-Bisson, RD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22704899
Citation
Subar AF, Kirkpatrick SI, Mittl B, Zimmerman TP, Thompson FE, Bingley C, Willis G, Islam NG, Baranowski T, McNutt S, Potischman N. The Automated Self-Administered 24-hour dietary recall (ASA24): a resource for researchers, clinicians, and educators from the National Cancer Institute. J Acad Nutr Diet. 2012 Aug;112(8):1134-7. doi: 10.1016/j.jand.2012.04.016. Epub 2012 Jun 15. No abstract available.
Results Reference
background
PubMed Identifier
22328929
Citation
Bansback N, Tsuchiya A, Brazier J, Anis A. Canadian valuation of EQ-5D health states: preliminary value set and considerations for future valuation studies. PLoS One. 2012;7(2):e31115. doi: 10.1371/journal.pone.0031115. Epub 2012 Feb 6.
Results Reference
background
PubMed Identifier
33347096
Citation
Devlin N, Parkin D, Janssen B. Methods for Analysing and Reporting EQ-5D Data [Internet]. Cham (CH): Springer; 2020. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK565678/
Results Reference
background
PubMed Identifier
21048977
Citation
Gloor GB, Hummelen R, Macklaim JM, Dickson RJ, Fernandes AD, MacPhee R, Reid G. Microbiome profiling by illumina sequencing of combinatorial sequence-tagged PCR products. PLoS One. 2010 Oct 26;5(10):e15406. doi: 10.1371/journal.pone.0015406.
Results Reference
background
PubMed Identifier
27143475
Citation
Gloor GB, Wu JR, Pawlowsky-Glahn V, Egozcue JJ. It's all relative: analyzing microbiome data as compositions. Ann Epidemiol. 2016 May;26(5):322-9. doi: 10.1016/j.annepidem.2016.03.003. Epub 2016 Apr 2.
Results Reference
background
PubMed Identifier
24910773
Citation
Fernandes AD, Reid JN, Macklaim JM, McMurrough TA, Edgell DR, Gloor GB. Unifying the analysis of high-throughput sequencing datasets: characterizing RNA-seq, 16S rRNA gene sequencing and selective growth experiments by compositional data analysis. Microbiome. 2014 May 5;2:15. doi: 10.1186/2049-2618-2-15. eCollection 2014.
Results Reference
background
PubMed Identifier
29808030
Citation
Zierer J, Jackson MA, Kastenmuller G, Mangino M, Long T, Telenti A, Mohney RP, Small KS, Bell JT, Steves CJ, Valdes AM, Spector TD, Menni C. The fecal metabolome as a functional readout of the gut microbiome. Nat Genet. 2018 Jun;50(6):790-795. doi: 10.1038/s41588-018-0135-7. Epub 2018 May 28.
Results Reference
background
PubMed Identifier
25201272
Citation
Abdel Rahman AM, Pawling J, Ryczko M, Caudy AA, Dennis JW. Targeted metabolomics in cultured cells and tissues by mass spectrometry: method development and validation. Anal Chim Acta. 2014 Oct 3;845:53-61. doi: 10.1016/j.aca.2014.06.012. Epub 2014 Jun 12.
Results Reference
background

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Assessing the Effect of a Mineral-enriched Powder on Iron Deficiency in Women of Reproductive Age

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