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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
Sponsor:
Collaborators:
University of KwaZulu
University of Nairobi
Information provided by (Responsible Party):
Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Bacterial Infections Dietary Supplement: fortification with iron and micronutrients Dietary Supplement: Sprinkles Not Applicable

Study Design
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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

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Arms and Interventions
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Arm Intervention/treatment
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
 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.


Outcome Measures
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Primary Outcome Measures :
  1. gut microbiota composition [ Time Frame: Fecal sample after 2 months ]
    Changes in gut microbiota composition


Secondary Outcome Measures :
  1. iron status [ Time Frame: 12 months ]
    Efficacy of iron fortification in complementary foods


Eligibility Criteria
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Ages Eligible for Study:   24 Weeks to 28 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Kenya
Kikoneni Clinic
Kikoneni, Kwale district, Kenya
Sponsors and Collaborators
Swiss Federal Institute of Technology
University of KwaZulu
University of Nairobi
Investigators
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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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Additional relevant MeSH terms:
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Bacterial Infections
Bacterial Infections and Mycoses
Infections
 Micronutrients
Trace Elements
Physiological Effects of Drugs