Iron Absorption in Haiti

Iron Deficiency Clinical Trial

Official title:

Iron Absorption From Wheat Flour in Haiti

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02096250
• Other study ID #: EK 2013-N43
• Status: Completed
• Phase: N/A
• First received: March 21, 2014
• Last updated: September 22, 2015
• Start date: June 2014
• Est. completion date: July 2015

Study information

• Verified date: September 2015
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethics Commission of ETH Zurich
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: July 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron Deficiency

Intervention

Other:
• NaFeEDTA

• Ferrous fumarate

• NaFeEDTA + ferrous fumarate

Locations

Country	Name	City	State
Haiti	Ministère de la Santé Publique et de la Population	Port au Prince

Sponsors (2)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology	International Atomic Energy Agency

Country where clinical trial is conducted

Haiti, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Iron absorption		14 days after test meal consumption	No