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The Optimization of Bioavailability From Iron Supplements: Study 1

Primary Purpose

Iron Deficiency, Anemia, Iron Deficiency Anemia

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Daily administration of 60 mg iron in form of ferrous sulphate capsules for 14 consecutive days
Administrations of 60 mg iron in form of ferrous sulphate capsules on every second day for 28 days
Sponsored by
Swiss Federal Institute of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Iron Deficiency focused on measuring Iron bio availability, Hepcidin, Iron absorption

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Female, 18 to 45 years old,
  • Serum ferritin levels </=25 µg/L,
  • Normal body Mass Index (18.5-26.5 kg/m2),
  • Body weight <80 kg,
  • Signed informed consent

Exclusion Criteria:

  • Anaemia (Hb < 8.0 g/dL),
  • Elevated c-reactive protein or alpha1-glycoprotein concentrations >5.0 mg/L, >1.0 g/L, respectively,
  • 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,
  • Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 4 months,
  • Earlier participation in a study using stable iron isotopes,
  • Known hypersensitivity or allergy to iron supplements,
  • Women who are pregnant or breast feeding,
  • Intention to become pregnant during the course of the studies,
  • 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, injectable, 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 abuse,
  • Inability to follow the procedures of the studies, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
  • Participation in another study with investigational drug within the 30 days preceding and during the present studies,
  • Enrolment of the investigator, his/her family members, employees and other dependent persons

Sites / Locations

  • Human Nutrition Laboratory

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Oral iron supplement every day for 14 days

Oral iron supplement every second day for 28 days

Arm Description

Daily administration of 60 mg iron in form of ferrous sulphate capsules for 14 consecutive days

Administrations of 60 mg iron in form of ferrous sulphate capsules on every second day for 28 days

Outcomes

Primary Outcome Measures

Iron bio-availability from oral iron supplementation (%)
Iron bioavailability will be assessed with stable isotopic labels. The shift in the isotopic ratio in human whole blood will be measured with Inductively coupled plasma mass spectrometry (ICP-MS).
Serum hepcidin concentrations

Secondary Outcome Measures

Full Information

First Posted
June 25, 2014
Last Updated
November 3, 2017
Sponsor
Swiss Federal Institute of Technology
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1. Study Identification

Unique Protocol Identification Number
NCT02175888
Brief Title
The Optimization of Bioavailability From Iron Supplements: Study 1
Official Title
The Optimization of Bioavailability From Iron Supplements: Examinations of Different Supplementation Regimens Including Hepcidin Profiles
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swiss Federal Institute of Technology

4. Oversight

5. Study Description

Brief Summary
Iron deficiency (ID) with or without anaemia (IDA) is a major public health problem worldwide, especially in women of reproductive age and young children. Iron supplementation is an effective strategy to prevent and treat ID and IDA. There is a lack of data on iron bioavailability from different supplementation regimens and how to optimize bioavailability in a cost-effective and patient-friendly way. The present study will test whether the fractional and total iron absorption from iron supplements (60 mg) administered daily for 14 days differs from that of iron supplements (60 mg) administered every second day for 28 days. The prevailing serum hepcidin concentration (SHep) is the major determinant of iron absorption and erythrocyte iron utilization. Therefore we will monitor SHep during the whole supplementation period. We hypothesize that the fractional and total iron absorption from the daily administration of 60 mg is lower than that from the administration on every second day due to increased SHep levels when supplements are administered daily. The study will provide important insights about the optimization of iron bioavailability from different supplementation regimens including the performance of SHep, a key regulator of human iron metabolism.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency, Anemia, Iron Deficiency Anemia
Keywords
Iron bio availability, Hepcidin, Iron absorption

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral iron supplement every day for 14 days
Arm Type
Experimental
Arm Description
Daily administration of 60 mg iron in form of ferrous sulphate capsules for 14 consecutive days
Arm Title
Oral iron supplement every second day for 28 days
Arm Type
Active Comparator
Arm Description
Administrations of 60 mg iron in form of ferrous sulphate capsules on every second day for 28 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Daily administration of 60 mg iron in form of ferrous sulphate capsules for 14 consecutive days
Intervention Type
Dietary Supplement
Intervention Name(s)
Administrations of 60 mg iron in form of ferrous sulphate capsules on every second day for 28 days
Primary Outcome Measure Information:
Title
Iron bio-availability from oral iron supplementation (%)
Description
Iron bioavailability will be assessed with stable isotopic labels. The shift in the isotopic ratio in human whole blood will be measured with Inductively coupled plasma mass spectrometry (ICP-MS).
Time Frame
up to 4 weeks
Title
Serum hepcidin concentrations
Time Frame
1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 17, 19, 21, 23, 25 and 27 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Female, 18 to 45 years old, Serum ferritin levels </=25 µg/L, Normal body Mass Index (18.5-26.5 kg/m2), Body weight <80 kg, Signed informed consent Exclusion Criteria: Anaemia (Hb < 8.0 g/dL), Elevated c-reactive protein or alpha1-glycoprotein concentrations >5.0 mg/L, >1.0 g/L, respectively, 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, Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 4 months, Earlier participation in a study using stable iron isotopes, Known hypersensitivity or allergy to iron supplements, Women who are pregnant or breast feeding, Intention to become pregnant during the course of the studies, 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, injectable, 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 abuse, Inability to follow the procedures of the studies, e.g. due to language problems, psychological disorders, dementia, etc. of the participant, Participation in another study with investigational drug within the 30 days preceding and during the present studies, Enrolment of the investigator, his/her family members, employees and other dependent persons
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diego Moretti, PhD
Organizational Affiliation
Human Nutrition Laboratory, ETH Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Human Nutrition Laboratory
City
Zurich
ZIP/Postal Code
8092
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
34038558
Citation
Lazrak M, El Kari K, Stoffel NU, Elammari L, Al-Jawaldeh A, Loechl CU, Yahyane A, Barkat A, Zimmermann MB, Aguenaou H. Tea Consumption Reduces Iron Bioavailability from NaFeEDTA in Nonanemic Women and Women with Iron Deficiency Anemia: Stable Iron Isotope Studies in Morocco. J Nutr. 2021 Sep 4;151(9):2714-2720. doi: 10.1093/jn/nxab159.
Results Reference
derived
PubMed Identifier
29032957
Citation
Stoffel NU, Cercamondi CI, Brittenham G, Zeder C, Geurts-Moespot AJ, Swinkels DW, Moretti D, Zimmermann MB. Iron absorption from oral iron supplements given on consecutive versus alternate days and as single morning doses versus twice-daily split dosing in iron-depleted women: two open-label, randomised controlled trials. Lancet Haematol. 2017 Nov;4(11):e524-e533. doi: 10.1016/S2352-3026(17)30182-5. Epub 2017 Oct 9.
Results Reference
derived

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The Optimization of Bioavailability From Iron Supplements: Study 1

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