Iron Absorption in Haiti

September 22, 2015 updated by: Isabelle Aeberli, Swiss Federal Institute of Technology

Iron Absorption From Wheat Flour in Haiti

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

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

  • Haiti
      • Port au Prince, Haiti
        • Ministère de la Santé Publique et de la Population

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

All

Description

Mother-child pairs will be recruited!

Inclusion criteria for mothers :

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

Exclusion criteria for mothers :

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

Inclusion criteria for children:

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

Exclusion criteria for children :

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

Furthermore, the following exclusion criteria apply to both mothers and children :

  • 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)

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: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: NaFeEDTA
Other: NaFeEDTA
EXPERIMENTAL: Ferrous fumarate
Other: Ferrous fumarate
EXPERIMENTAL: NaFeEDTA + ferrous fumarate
Other: NaFeEDTA + ferrous fumarate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Iron absorption
Time Frame: 14 days after test meal consumption
14 days after test meal consumption

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swiss Federal Institute of Technology

Collaborators

International Atomic Energy Agency

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, 2014

Primary Completion (ACTUAL)

August 1, 2014

Study Completion (ACTUAL)

July 1, 2015

Study Registration Dates

First Submitted

March 21, 2014

First Submitted That Met QC Criteria

March 24, 2014

First Posted (ESTIMATE)

March 26, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

September 23, 2015

Last Update Submitted That Met QC Criteria

September 22, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK 2013-N43

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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