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

NCT01111864 | Completed DMC

• 1 other identifier: 2-cercamondi
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Bacterial Infections

Outcome Measures

Primary Outcomes (1)

• gut microbiota composition

  Changes in gut microbiota composition

  Fecal sample after 2 months

Secondary Outcomes (1)

• iron status

  12 months

Study Arms (4)

MixMe powder (iron & micronutrients)

EXPERIMENTAL

Dietary Supplement: fortification with iron and micronutrients

MixMe powder (micronutrients, no iron)

PLACEBO COMPARATOR

Dietary Supplement: fortification with iron and micronutrients

Sprinkles (iron and micronutrients)

EXPERIMENTAL

Vitamin A 300 µg; Vitamin C 30 mg; Folic Acid 160 µg; Iron 12.5 mg; Zinc 5 mg

Dietary Supplement: Sprinkles

Sprinkles (micronutrients, no iron)

PLACEBO COMPARATOR

Vitamin A 300 µg; Vitamin C 30 mg; Folic Acid 160 µg; Zinc 5 mg

Dietary Supplement: Sprinkles

Interventions

fortification with iron and micronutrients DIETARY_SUPPLEMENT

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

MixMe powder (iron & micronutrients); MixMe powder (micronutrients, no iron)

Sprinkles DIETARY_SUPPLEMENT

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.

Sprinkles (iron and micronutrients); Sprinkles (micronutrients, no iron)

Eligibility Criteria

• Age: 24 Weeks - 28 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead
• University of KwaZulu: collaborator
• University of Nairobi: collaborator

Study Sites (1)

Kikoneni Clinic

Kikoneni, Kwale County, Kenya

Location

Related Publications (1)

• Jaeggi T, Kortman GA, Moretti D, Chassard C, Holding P, Dostal A, Boekhorst J, Timmerman HM, Swinkels DW, Tjalsma H, Njenga J, Mwangi A, Kvalsvig J, Lacroix C, Zimmermann MB. Iron fortification adversely affects the gut microbiome, increases pathogen abundance and induces intestinal inflammation in Kenyan infants. Gut. 2015 May;64(5):731-42. doi: 10.1136/gutjnl-2014-307720. Epub 2014 Aug 20.

  PMID: 25143342 DERIVED

MeSH Terms

Conditions

Bacterial Infections

Interventions

Iron; Micronutrients

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Nutrients; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Michael B Zimmermann, M.D.

  Human Nutrition Laboratory, Swiss Federal Institute of Technology

  STUDY DIRECTOR

• Jane Kvalsvig, PhD

  Department of Public Health Medicine, Nelson Mandela School of Medicine, South Africa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: April 23, 2010
• First Posted: April 28, 2010
• Study Start: February 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: October 1, 2012
• Last Updated: June 7, 2013

Record last verified: 2013-06

Locations

KE (1)