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

This study has been completed.
Sponsor:
Collaborators:
University of KwaZulu
University of Nairobi
Information provided by (Responsible Party):
Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier:
NCT01111864
First received: April 23, 2010
Last updated: June 6, 2013
Last verified: June 2013
  Purpose

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 Intervention
Bacterial Infections
Dietary Supplement: fortification with iron and micronutrients
Dietary Supplement: Sprinkles

Study Type: Interventional
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
Official Title: The Effect of Iron Fortification of Complementary Foods on Iron Status and Infant Gut Microbiota in Kenya

Resource links provided by NLM:


Further study details as provided by Swiss Federal Institute of Technology:

Primary Outcome Measures:
  • gut microbiota composition [ Time Frame: Fecal sample after 2 months ] [ Designated as safety issue: Yes ]
    Changes in gut microbiota composition


Secondary Outcome Measures:
  • iron status [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Efficacy of iron fortification in complementary foods


Enrollment: 160
Study Start Date: February 2010
Study Completion Date: October 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   24 Weeks to 28 Weeks
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01111864

Locations
Kenya
Kikoneni Clinic
Kikoneni, Kwale district, Kenya
Sponsors and Collaborators
Swiss Federal Institute of Technology
University of KwaZulu
University of Nairobi
Investigators
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

No publications provided

Responsible Party: Prof. Michael B. Zimmermann, Prof, Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier: NCT01111864     History of Changes
Other Study ID Numbers: 2-cercamondi
Study First Received: April 23, 2010
Last Updated: June 6, 2013
Health Authority: Kenya: Ethical Review Committee

Additional relevant MeSH terms:
Bacterial Infections
Micronutrients
Iron
Trace Elements
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014