Changes in Microbiota and Iron Status After Iron Fortification of Complementary Foods
Information source: Swiss Federal Institute of Technology
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bacterial Infections
Intervention: fortification with iron and micronutrients (Dietary Supplement); Sprinkles (Dietary Supplement)
Phase: N/A
Status: Completed
Sponsored by: Swiss Federal Institute of Technology Official(s) and/or principal investigator(s): Michael B Zimmermann, M.D., Study Director, Affiliation: Human Nutrition Laboratory, Swiss Federal Institute of Technology Jane Kvalsvig, PhD, Principal Investigator, Affiliation: Department of Public Health Medicine, Nelson Mandela School of Medicine, South Africa
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.
Clinical Details
Official title: The Effect of Iron Fortification of Complementary Foods on Iron Status and Infant Gut Microbiota in Kenya
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
Primary outcome: gut microbiota composition
Secondary outcome: iron status
Eligibility
Minimum age: 24 Weeks.
Maximum age: 28 Weeks.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Kikoneni Clinic, Kikoneni, Kwale district, Kenya
Additional Information
Starting date: February 2010
Last updated: June 6, 2013
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