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Determination of a Dose-dependent Effect of GOS on Iron Absorption, and Addition of Vitamin C (Fe_GOS_2)

Primary Purpose

Iron-deficiency

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
ferrous fumarate
ferrous sulphate
ferric pyrophosphate
ferrous fumarate + 3.5 g GOS
ferrous fumarate + 7 g GOS
ferrous sulphate + 15 g GOS
ferrous fumarate + Vitamin C
ferric pyrophosphate + 15 g GOS
ferrous fumarate + 7 g GOS + Vitamin C
Sponsored by
Isabelle Herter-Aeberli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Iron-deficiency focused on measuring iron-deficiency, prebiotics, galacto-oligosaccharides

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Female, 18 to 45 years old
  • SF levels <30 µg/L
  • Normal body Mass Index (18.5-24.9 kg/m2)
  • Body weight <70 kg
  • Signed informed consent

Exclusion Criteria:

  • Severe anaemia (Hb < 80 g/L)
  • Elevated CRP >10.0 mg/L
  • Any metabolic, gastrointestinal kidney or chronic disease such as diabetes, renal failure, hepatic dysfunction, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement)
  • Continuous/long-term use of medication during the whole studies (except for contraceptives)
  • Consumption of mineral and vitamin supplements within 2 weeks prior to 1st supplement administration, including pre- and-or probiotics supplements (excluding foods and beverages with life cultures such as yoghurt, raw milk cheese and kombucha)
  • Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 4 months
  • Difficulties with blood sampling
  • Use of antibiotics over the past month
  • Known hypersensitivity to iron supplements in the given amount, GOS, or lactose
  • Women who are pregnant or breast feeding
  • Women who intend become pregnant during the course of the study
  • Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, inject-able, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases
  • Known or suspected non-compliance, drug or alcohol (more than 2 drinks/day) abuse -
  • Smokers (> 1 cigarette per week)
  • Inability to follow the procedures of the study, e.g. due to language problems, self-- reported psychological disorders, etc. of the participant
  • Enrollment of the investigator, his/her family members, employees and other dependent persons

Sites / Locations

  • Human Nutrition Laboratory, ETH Zurich

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

ferrous fumarate

ferrous sulphate

ferric pyrophosphate

ferrous fumarate + 3.5 g GOS

ferrous fumarate + 7 g GOS

ferrous sulphate + 15 g GOS

ferrous fumarate + Vitamin C

ferric pyrophosphate + 15 g GOS

ferrous fumarate + 7 g GOS + Vitamin C

Arm Description

labelled iron as ferrous fumarate

labelled iron as ferrous sulphate

labelled iron as ferric pyrophosphate

labelled iron as ferrous fumarate + prebiotics in the form of 3.5 g GOS

labelled iron as ferrous fumarate + prebiotics in the form of 7 g GOS

labelled iron as ferrous sulphate + prebiotics in the form of 15 g GOS

labelled iron as ferrous fumarate + Vitamin C

labelled iron as ferric pyrophosphate + prebiotics in the form of 15 g GOS

labelled iron as ferrous fumarate + prebiotics in the form of 7 g GOS + Vitamin C

Outcomes

Primary Outcome Measures

fractional iron absorption
Fractional iron absorption will be calculated based on the shift of the iron isotope ratios in the collected blood samples after the administration of several isotopically labelled iron supplements.Fractional iron absorption will be measured as erythrocyte incorporation of the naturally occurring iron forms with different masses used to label the iron supplements.

Secondary Outcome Measures

Full Information

First Posted
November 30, 2018
Last Updated
July 24, 2019
Sponsor
Isabelle Herter-Aeberli
Collaborators
Burgerstein Vitamine
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1. Study Identification

Unique Protocol Identification Number
NCT03762148
Brief Title
Determination of a Dose-dependent Effect of GOS on Iron Absorption, and Addition of Vitamin C
Acronym
Fe_GOS_2
Official Title
The Effect of Prebiotics on Iron Absorption in Women With Low Iron Stores: Determination of a Dose-dependent Effect of Galacto-oligosaccharides on Iron Absorption, With and Without Addition of Ascorbic Acid
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
June 11, 2019 (Actual)
Study Completion Date
June 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Isabelle Herter-Aeberli
Collaborators
Burgerstein Vitamine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Iron deficiency is still the most common and widespread nutritional disorder in the world according to WHO. In a recent iron absorption study in adult women with low iron stores in our lab (publication under review), we found that 15 g of GOS given with an iron supplement in the form of iron fumarate acutely increased iron absorption when given with water and a bread based meal. The dose of 15 g of GOS was tolerated well by the participants. As a follow up to the study mentioned above, we want to investigate: 1) if acute iron absorption is affected by lower doses of GOS; 2) whether this acute effect occurs for other commonly used iron compounds as well, such as iron sulphate and iron phosphate; and 3) if there are potential interactions on absorption with other enhancers of iron absorption, such as vitamin c.
Detailed Description
Iron is an important mineral in our body and fulfills essential functions such as for example oxygen transport from the lungs to the tissues. Iron deficiency is still the most common and widespread nutritional disorder in the world according to WHO. Common iron supplements all have their limitations in terms of availability and compatibility. Prebiotic fibers, such as galacto-oligosaccharides (GOS), selectively enhance growth of beneficial colonic bacteria. Prebiotics in general enhance the production of short-chain fatty acids (SCFAs) and thereby decrease luminal pH. Through the reduction in pH, prebiotics can enhance absorption of minerals such as calcium and magnesium and they have been proposed to potentially improve iron absorption. In a recent iron absorption study in adult women with low iron stores in our lab (publication under review), we found that 15 g of GOS given with an iron supplement in the form of iron fumarate acutely increased iron absorption when given with water and a bread based meal. The dose of 15 g of GOS was tolerated well by the participants. As a follow up to the study mentioned above, we want to investigate: 1) if acute iron absorption is affected by lower doses of GOS; 2) whether this acute effect occurs for other commonly used iron compounds as well, such as iron sulphate and iron phosphate; and 3) if there are potential interactions on absorption with other enhancers of iron absorption, such as vitamin c.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron-deficiency
Keywords
iron-deficiency, prebiotics, galacto-oligosaccharides

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ferrous fumarate
Arm Type
Experimental
Arm Description
labelled iron as ferrous fumarate
Arm Title
ferrous sulphate
Arm Type
Experimental
Arm Description
labelled iron as ferrous sulphate
Arm Title
ferric pyrophosphate
Arm Type
Experimental
Arm Description
labelled iron as ferric pyrophosphate
Arm Title
ferrous fumarate + 3.5 g GOS
Arm Type
Experimental
Arm Description
labelled iron as ferrous fumarate + prebiotics in the form of 3.5 g GOS
Arm Title
ferrous fumarate + 7 g GOS
Arm Type
Experimental
Arm Description
labelled iron as ferrous fumarate + prebiotics in the form of 7 g GOS
Arm Title
ferrous sulphate + 15 g GOS
Arm Type
Experimental
Arm Description
labelled iron as ferrous sulphate + prebiotics in the form of 15 g GOS
Arm Title
ferrous fumarate + Vitamin C
Arm Type
Experimental
Arm Description
labelled iron as ferrous fumarate + Vitamin C
Arm Title
ferric pyrophosphate + 15 g GOS
Arm Type
Experimental
Arm Description
labelled iron as ferric pyrophosphate + prebiotics in the form of 15 g GOS
Arm Title
ferrous fumarate + 7 g GOS + Vitamin C
Arm Type
Experimental
Arm Description
labelled iron as ferrous fumarate + prebiotics in the form of 7 g GOS + Vitamin C
Intervention Type
Dietary Supplement
Intervention Name(s)
ferrous fumarate
Intervention Description
nutritional iron (14 mg) supplement in form of ferrous fumarate
Intervention Type
Dietary Supplement
Intervention Name(s)
ferrous sulphate
Intervention Description
nutritional iron (14 mg) supplement in form of ferrous sulphate
Intervention Type
Dietary Supplement
Intervention Name(s)
ferric pyrophosphate
Intervention Description
nutritional iron (14 mg) supplement in form of ferric pyrophosphate
Intervention Type
Dietary Supplement
Intervention Name(s)
ferrous fumarate + 3.5 g GOS
Intervention Description
nutritional iron (14 mg) supplement in form of ferrous fumarate with addition of prebiotics (3.5 g GOS)
Intervention Type
Dietary Supplement
Intervention Name(s)
ferrous fumarate + 7 g GOS
Intervention Description
nutritional iron (14 mg) supplement in form of ferrous fumarate with addition of prebiotics (7 g GOS)
Intervention Type
Dietary Supplement
Intervention Name(s)
ferrous sulphate + 15 g GOS
Intervention Description
nutritional iron (14 mg) supplement in form of ferrous sulphate with addition of prebiotics (15 g GOS)
Intervention Type
Dietary Supplement
Intervention Name(s)
ferrous fumarate + Vitamin C
Intervention Description
nutritional iron (14 mg) supplement in form of ferrous fumarate with addition of Vitamin C
Intervention Type
Dietary Supplement
Intervention Name(s)
ferric pyrophosphate + 15 g GOS
Intervention Description
nutritional iron (14 mg) supplement in form of ferric pyrophosphate with addition of prebiotics (15 g GOS)
Intervention Type
Dietary Supplement
Intervention Name(s)
ferrous fumarate + 7 g GOS + Vitamin C
Intervention Description
nutritional iron (14 mg) supplement in form of ferrous fumarate with addition of prebiotics (7 g GOS) and Vitamin C
Primary Outcome Measure Information:
Title
fractional iron absorption
Description
Fractional iron absorption will be calculated based on the shift of the iron isotope ratios in the collected blood samples after the administration of several isotopically labelled iron supplements.Fractional iron absorption will be measured as erythrocyte incorporation of the naturally occurring iron forms with different masses used to label the iron supplements.
Time Frame
2 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Only female participants are being studied
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female, 18 to 45 years old SF levels <30 µg/L Normal body Mass Index (18.5-24.9 kg/m2) Body weight <70 kg Signed informed consent Exclusion Criteria: Severe anaemia (Hb < 80 g/L) Elevated CRP >10.0 mg/L Any metabolic, gastrointestinal kidney or chronic disease such as diabetes, renal failure, hepatic dysfunction, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement) Continuous/long-term use of medication during the whole studies (except for contraceptives) Consumption of mineral and vitamin supplements within 2 weeks prior to 1st supplement administration, including pre- and-or probiotics supplements (excluding foods and beverages with life cultures such as yoghurt, raw milk cheese and kombucha) Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 4 months Difficulties with blood sampling Use of antibiotics over the past month Known hypersensitivity to iron supplements in the given amount, GOS, or lactose Women who are pregnant or breast feeding Women who intend become pregnant during the course of the study Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, inject-able, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases Known or suspected non-compliance, drug or alcohol (more than 2 drinks/day) abuse - Smokers (> 1 cigarette per week) Inability to follow the procedures of the study, e.g. due to language problems, self-- reported psychological disorders, etc. of the participant Enrollment of the investigator, his/her family members, employees and other dependent persons
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle Herter-Aeberli, Dr.
Organizational Affiliation
University of Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Human Nutrition Laboratory, ETH Zurich
City
Zurich
ZIP/Postal Code
8092
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32692367
Citation
Jeroense FMD, Zeder C, Zimmermann MB, Herter-Aeberli I. Acute Consumption of Prebiotic Galacto-Oligosaccharides Increases Iron Absorption from Ferrous Fumarate, but not from Ferrous Sulfate and Ferric Pyrophosphate: Stable Iron Isotope Studies in Iron-Depleted Young Women. J Nutr. 2020 Sep 1;150(9):2391-2397. doi: 10.1093/jn/nxaa199.
Results Reference
derived

Learn more about this trial

Determination of a Dose-dependent Effect of GOS on Iron Absorption, and Addition of Vitamin C

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