Skip to main content
OpenTrials
Completed

NCT Number: NCT02096250

Iron Absorption 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ministère de la Santé Publique et de la Population

Port-au-Prince, Haiti

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

NaFeEDTA

Other

Ferrous fumarate

Other

NaFeEDTA + ferrous fumarate

Other

Primary outcomes

  1. Iron absorption

    Time frame: 14 days after test meal consumption

Sponsors and collaborators

Lead sponsor

Swiss Federal Institute of Technology

Other

Collaborators

  • International Atomic Energy Agency

Registry information

Official study title

Iron Absorption From Wheat Flour in Haiti

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Mar 26, 2014
Registry last updated
Sep 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.