Changes in Microbiota and Iron Status After Iron Fortification of Complementary Foods
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ClinicalTrials.gov Identifier: NCT01111864 |
Recruitment Status :
Completed
First Posted : April 28, 2010
Last Update Posted : June 7, 2013
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Bacterial Infections | Dietary Supplement: fortification with iron and micronutrients Dietary Supplement: Sprinkles | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 160 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Basic Science |
Official Title: | The Effect of Iron Fortification of Complementary Foods on Iron Status and Infant Gut Microbiota in Kenya |
Study Start Date : | February 2010 |
Actual Primary Completion Date : | September 2012 |
Actual Study Completion Date : | October 2012 |

Arm | Intervention/treatment |
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Experimental: MixMe powder (iron & micronutrients) |
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 |
Placebo Comparator: MixMe powder (micronutrients, no iron) |
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 |
Experimental: Sprinkles (iron and micronutrients)
Vitamin A 300 µg; Vitamin C 30 mg; Folic Acid 160 µg; Iron 12.5 mg; Zinc 5 mg
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Dietary Supplement: 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. |
Placebo Comparator: Sprinkles (micronutrients, no iron)
Vitamin A 300 µg; Vitamin C 30 mg; Folic Acid 160 µg; Zinc 5 mg
|
Dietary Supplement: 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. |
- gut microbiota composition [ Time Frame: Fecal sample after 2 months ]Changes in gut microbiota composition
- iron status [ Time Frame: 12 months ]Efficacy of iron fortification in complementary foods

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Ages Eligible for Study: | 24 Weeks to 28 Weeks (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01111864
Kenya | |
Kikoneni Clinic | |
Kikoneni, Kwale district, Kenya |
Study Director: | Michael B Zimmermann, M.D. | Human Nutrition Laboratory, Swiss Federal Institute of Technology | |
Principal Investigator: | Jane Kvalsvig, PhD | Department of Public Health Medicine, Nelson Mandela School of Medicine, South Africa |
Responsible Party: | Prof. Michael B. Zimmermann, Prof, Swiss Federal Institute of Technology |
ClinicalTrials.gov Identifier: | NCT01111864 |
Other Study ID Numbers: |
2-cercamondi |
First Posted: | April 28, 2010 Key Record Dates |
Last Update Posted: | June 7, 2013 |
Last Verified: | June 2013 |
Bacterial Infections Bacterial Infections and Mycoses Infections |
Micronutrients Trace Elements Physiological Effects of Drugs |