Iron Absorption in Haiti

Federal Institute of Technology (ETH) Zurich

Status: Completed

Conditions: Iron Deficiency

Treatments: Other: NaFeEDTA + ferrous fumarate; Other: NaFeEDTA; Other: Ferrous fumarate

Study type: Interventional

Funder types: Other

Identifiers

NCT02096250

EK 2013-N43

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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44 participants in 3 patient groups

NaFeEDTA

Experimental group

Description:

NaFeEDTA

Treatment:

Other: NaFeEDTA

Ferrous fumarate

Experimental group

Description:

Ferrous fumarate

Treatment:

Other: Ferrous fumarate

NaFeEDTA + ferrous fumarate

Experimental group

Description:

NaFeEDTA + ferrous fumarate

Treatment:

Other: NaFeEDTA + ferrous fumarate