Changes in Microbiota and Iron Status After Iron Fortification of Complementary Foods

Federal Institute of Technology (ETH) Zurich

Status: Completed

Conditions: Bacterial Infections

Treatments: Dietary Supplement: Sprinkles; Dietary Supplement: fortification with iron and micronutrients

Study type: Interventional

Funder types: Other

Identifiers

NCT01111864

2-cercamondi

Details and patient eligibility

About

Infants and children under two years are the group with the highest rates of iron deficiency anemia. Provision of sufficient dietary iron to this age group is a challenge, and in-home iron fortification of complementary foods using micronutrient powders can be an effective approach. However, WHO has recently cautioned against untargeted use of in-home micronutrient powders that contain the entire iron RDA for a child in a single dose in areas with high rates of infections from malaria and diarrheal disease. Therefore, in this study, we will investigate the effect on the infant gut microbiota of a low dose (ca. 25% of the RDA) of highly bioavailable iron, provided by a micronutrient powder added to a complementary food.

The study aim is to determine if in-home fortification using an iron-containing micronutrient powder in Kenyan infants will improve iron status and/or modify the composition and metabolic activity of the gut microbiota. Active surveillance will be done weekly to monitor the health of the infants.

Our study will be done in a subgroup (n=160) of a larger double-blind controlled feeding trial in which 330 infants will be randomized to receive a micronutrient powder containing either 2.5 mg iron or no iron for 1 year. In our substudy, the infants will be studied only over the first 6 months of the 1 year intervention. Blood samples, taken at baseline and after 6 months will be used to define the iron status and the anemia level of the infants. Stool samples (2 at baseline before intervention, 6 throughout the study and additional samples in case of diarrhea) will be obtained for analysis of the gut microbiota. In the entire study (n=330), we will measure changes in iron status over 1 year.

Enrollment: 160 patients

Sex: All

Ages: 24 to 28 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Mother at least ≥15 years of age, infants 5.5- 6.5 months
• Willingness to provide informed consent
• Apparent good health
• Long-term residence in study site and anticipating residing in the area for at least 3 years
• Speak a Mjikenda language or Kiswahili in the home
• Willingness to provide blood samples during clinic visits

Exclusion criteria

• Hemoglobin <70 g/L for infants; these infants will be referred for treatment at the local health clinic/hospital.
• Acute or chronic pulmonary, cardiovascular, hepatic, renal or neurological condition or any other finding that in the opinion of the PI or co-researchers that would increase risk of participating in the study.
• Other conditions that in the opinion of the PI or co-researchers would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 4 patient groups, including a placebo group

MixMe powder (iron & micronutrients)

Experimental group

Treatment:

Dietary Supplement: fortification with iron and micronutrients

MixMe powder (micronutrients, no iron)

Placebo Comparator group

Treatment:

Dietary Supplement: fortification with iron and micronutrients

Sprinkles (iron and micronutrients)

Experimental group

Description:

Vitamin A 300 µg; Vitamin C 30 mg; Folic Acid 160 µg; Iron 12.5 mg; Zinc 5 mg

Treatment:

Dietary Supplement: Sprinkles

Sprinkles (micronutrients, no iron)

Placebo Comparator group

Description:

Vitamin A 300 µg; Vitamin C 30 mg; Folic Acid 160 µg; Zinc 5 mg

Treatment:

Dietary Supplement: Sprinkles