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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014