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The Optimization of Bioavailability From Iron Supplements: Study 2

Primary Purpose

Iron Deficiency, Anemia, Iron Deficiency Anemia

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Single oral iron dose of 120 mg per day for 3 consecutive days
Two oral iron doses of 60 mg per day (morning + afternoon) for 3 consecutive 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 <20 µg/L,
  • Normal body Mass Index (18.5-25 kg/m2),
  • Body weight <65 kg,
  • Signed informed consent

Exclusion Criteria:

  • Anaemia (Hb < 11.7 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

Single oral iron supplement per day (120 mg)

B.i.d. oral iron supplement (2x 60 mg)

Arm Description

Single oral iron dose of 120 mg per day for 3 consecutive days

Two oral iron doses of 60 mg per day (morning + afternoon) for 3 consecutive days

Outcomes

Primary Outcome Measures

Iron bio-availability (%) from oral iron supplementation (3x 120 mg)
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 on the 1st day of iron supplementation
Iron bio-availability (%) from oral iron supplementation (6x 60 mg)
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 on the 2nd day of iron supplementation
Serum hepcidin concentrations on the 3rd day of iron supplementation
Serum hepcidin concentrations on the 4th day of iron supplementation
Serum hepcidin concentrations on the 5th day of iron supplementation
Serum hepcidin concentrations on the 6th day of iron supplementation

Secondary Outcome Measures

Full Information

First Posted
June 25, 2014
Last Updated
January 20, 2016
Sponsor
Swiss Federal Institute of Technology
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1. Study Identification

Unique Protocol Identification Number
NCT02177851
Brief Title
The Optimization of Bioavailability From Iron Supplements: Study 2
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
September 2015
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
December 2015 (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 daily supplementation with 1-4 mg Fe/kg body weight for 3 months is reported to be the most effective method to rapidly increase iron stores in subjects with ID and IDA. In IDA patients, medical practitioners often prescribe supplementation regimens with 120 mg iron per day split into 2 doses with 60 mg iron, arguing that the splitting would increase iron bioavailability compared with one single high dose. However, there is no scientific evidence for this assumption; to the contrary, results from a recent study suggest that iron bioavailability from a second supplementation dose of iron after a first supplementation dose of iron is impaired due to increased hepcidin levels. To address this bioavailability issue, the present study will determine iron absorption from 120 mg iron administered for 3 consecutive days and compare it with that from 2 doses of 60 mg iron per day administered for 3 consecutive days. The investigators hypothesize that the iron bioavailability from the single daily dose will be lower than that from the 2 doses. By measuring also hepcidin, this study will provide important insights on the iron bioavailability from a single dose of iron and on the same amount iron split into two doses (b.i.d. administration).

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
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single oral iron supplement per day (120 mg)
Arm Type
Experimental
Arm Description
Single oral iron dose of 120 mg per day for 3 consecutive days
Arm Title
B.i.d. oral iron supplement (2x 60 mg)
Arm Type
Active Comparator
Arm Description
Two oral iron doses of 60 mg per day (morning + afternoon) for 3 consecutive days
Intervention Type
Dietary Supplement
Intervention Name(s)
Single oral iron dose of 120 mg per day for 3 consecutive days
Intervention Type
Dietary Supplement
Intervention Name(s)
Two oral iron doses of 60 mg per day (morning + afternoon) for 3 consecutive days
Primary Outcome Measure Information:
Title
Iron bio-availability (%) from oral iron supplementation (3x 120 mg)
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
3 days
Title
Serum hepcidin concentrations on the 1st day of iron supplementation
Time Frame
1 day
Title
Iron bio-availability (%) from oral iron supplementation (6x 60 mg)
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
6 days
Title
Serum hepcidin concentrations on the 2nd day of iron supplementation
Time Frame
2 days
Title
Serum hepcidin concentrations on the 3rd day of iron supplementation
Time Frame
3 days
Title
Serum hepcidin concentrations on the 4th day of iron supplementation
Time Frame
4 days
Title
Serum hepcidin concentrations on the 5th day of iron supplementation
Time Frame
5 days
Title
Serum hepcidin concentrations on the 6th day of iron supplementation
Time Frame
6 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 <20 µg/L, Normal body Mass Index (18.5-25 kg/m2), Body weight <65 kg, Signed informed consent Exclusion Criteria: Anaemia (Hb < 11.7 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
Facility Information:
Facility Name
Human Nutrition Laboratory
City
Zurich
ZIP/Postal Code
8092
Country
Switzerland

12. IPD Sharing Statement

Citations:
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
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The Optimization of Bioavailability From Iron Supplements: Study 2

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