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

Bacterial Infections Clinical Trial

Official title:

The Effect of Iron Fortification of Complementary Foods on Iron Status and Infant Gut Microbiota in Kenya

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01111864
• Other study ID #: 2-cercamondi
• Status: Completed
• Phase: N/A
• First received: April 23, 2010
• Last updated: June 6, 2013
• Start date: February 2010
• Est. completion date: October 2012

Study information

• Verified date: June 2013
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Kenya: Ethical Review Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: October 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 24 Weeks to 28 Weeks

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Bacterial Infections

Intervention

Dietary Supplement:
• fortification with iron and micronutrients
Iron 0 or 2.5 mg; Copper 0.34 mg; 30 µg Iodine; 7 µg Selenium; 2.5 mg Zinc; 100 µg Vitamin A; Vitamin D 5 µg; 5 mg Tocopherol Equivalent; 30 µg Vitamin K1; 10.5 mg Thiamine; 0.5 mg Riboflavin; 0.5 mg Pyridoxine; 90 µg Folic Acid Anhydrous; 6 mg Niacinamide; 60 mg Vitamin C; 0.9 µg Vitamin B12
• Sprinkles
Daily 12.5mg Ferrous fumarate iron with microntrient is compared to no iron with micronutrients. Duration of intervention is 4 months, 80 infants will be inclulded.

Locations

Country	Name	City	State
Kenya	Kikoneni Clinic	Kikoneni	Kwale district

Sponsors (3)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology	University of KwaZulu, University of Nairobi

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	gut microbiota composition	Changes in gut microbiota composition	Fecal sample after 2 months	Yes
Secondary	iron status	Efficacy of iron fortification in complementary foods	12 months	Yes