Iron Absorption in Haiti

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-07-31

Brief Summary

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The government of Haiti plans to introduce a flour fortification program. The aim of the project it to inform the authorities on the most suitable iron compound for this fortification program. For this purpose, iron absorption from wheat flour using different iron compounds will be investigated.

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Detailed Description

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Conditions

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Iron Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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NaFeEDTA

Group Type EXPERIMENTAL

NaFeEDTA

Intervention Type OTHER

Ferrous fumarate

Group Type EXPERIMENTAL

Ferrous fumarate

Intervention Type OTHER

NaFeEDTA + ferrous fumarate

Group Type EXPERIMENTAL

NaFeEDTA + ferrous fumarate

Intervention Type OTHER

Interventions

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NaFeEDTA

Intervention Type OTHER

Ferrous fumarate

Intervention Type OTHER

NaFeEDTA + ferrous fumarate

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Women of reproductive age (18 to 45 years)
* Generally healthy
* Consenting to study participation

* Age 4 years +/- 12 months
* Generally healthy

Exclusion Criteria

* Pregnancy or lactation
* Weight \>65 kg
* Chronic illnesses which may influence iron absorption
* Severe anemia (Hb\<10 g/dl)

* Severe anemia (Hb\<10 g/dl)
* Weight for height \< -2 Z scores (wasting)
* Height of age \< -2 Z score (stunting)

* Chronic illnesses or medication which may influence iron absorption (will be judged by investigator)
* Consumption of vitamin or mineral supplement (unless they agree to discontinue using them two weeks before beginning of the study until the las visit)
* Allergies or intolerances relevant to the test meal (gluten)
* Blood donation or major blood losses during the 2 months prior to the study
* Illness during the 4 weeks prior to the study (will be judged by investigator)

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes