- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02177851
The Optimization of Bioavailability From Iron Supplements: Study 2
January 20, 2016 updated by: Swiss Federal Institute of Technology
The Optimization of Bioavailability From Iron Supplements: Examinations of Different Supplementation Regimens Including Hepcidin Profiles
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).
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Zurich, Switzerland, 8092
- Human Nutrition Laboratory
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single oral iron supplement per day (120 mg)
Single oral iron dose of 120 mg per day for 3 consecutive days
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|
Active Comparator: B.i.d. oral iron supplement (2x 60 mg)
Two oral iron doses of 60 mg per day (morning + afternoon) for 3 consecutive days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Iron bio-availability (%) from oral iron supplementation (3x 120 mg)
Time Frame: 3 days
|
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).
|
3 days
|
Serum hepcidin concentrations on the 1st day of iron supplementation
Time Frame: 1 day
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1 day
|
|
Iron bio-availability (%) from oral iron supplementation (6x 60 mg)
Time Frame: 6 days
|
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).
|
6 days
|
Serum hepcidin concentrations on the 2nd day of iron supplementation
Time Frame: 2 days
|
2 days
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|
Serum hepcidin concentrations on the 3rd day of iron supplementation
Time Frame: 3 days
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3 days
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Serum hepcidin concentrations on the 4th day of iron supplementation
Time Frame: 4 days
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4 days
|
|
Serum hepcidin concentrations on the 5th day of iron supplementation
Time Frame: 5 days
|
5 days
|
|
Serum hepcidin concentrations on the 6th day of iron supplementation
Time Frame: 6 days
|
6 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2015
Primary Completion (Actual)
September 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
June 25, 2014
First Submitted That Met QC Criteria
June 26, 2014
First Posted (Estimate)
June 30, 2014
Study Record Updates
Last Update Posted (Estimate)
January 21, 2016
Last Update Submitted That Met QC Criteria
January 20, 2016
Last Verified
September 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FeSupp_Hep-2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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