Effect of Sprinkles With and w/o Fe on Zn Absorption in Kenyan Toddlers

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Micronutrient Deficiencies

Treatments: Dietary Supplement: MNP + Zn; Dietary Supplement: MNP + Zn/Fe; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02101723

16933

K24DK083772 (U.S. NIH Grant/Contract)

11-0227

15827 (Other Grant/Funding Number)

Details and patient eligibility

About

The investigators propose to study the effects of increased iron intake by home fortification of complementary foods on the gastrointestinal microbial development, inflammatory responses, and zinc (Zn) absorption. The proposed subjects are 9 month olds living in a malaria endemic area of rural Kenya who are randomized at 6 months of age to one of three fortificant groups: 1) Sprinkles™ with 12mg Iron(Fe)/day + other micronutrients, including 5mg/d Zn (test); Sprinkles™ with 0 mg/d Fe + other micronutrients, including 5mg/d Zn (control); Sprinkles™ with no micronutrients (placebo). The investigators hypothesize that the microbiome will be significantly different in the three groups and that Zn absorption and status, in addition to immune and oxidant status will be improved in the non-Fe fortified groups when compared to the Fe-fortified group.

Full description

Specific aims include exploration of possible mechanisms of adverse events that have been observed in iron supplementation trials in infants in malaria endemic regions by:

1. Characterizing the impact of enteral iron administration on the evolution of the intestinal microbiome in infants from 6 to 9 months of age.

2. Characterizing iron administration-associated inflammatory responses and correlate these with changes in the intestinal microbiome in infants from 6 to 9 months of age. Specifically, changes in the microbiome will be correlated with biomarkers reflecting:

   1. Intestinal inflammation;
   2. Systemic inflammation, bacterial translocation, and oxidant stress;
   3. Iron status and homeostasis

3. Quantify to what degree Fe interferes with Zn absorption (TAZ) and how it affects the size of the infant's exchangeable zinc pool (EZP).

Enrollment: 63 patients

Sex: All

Ages: 5 to 10 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Term infant
• Birthweight > 2500 g
• Healthy with no apparent congenital anomalies
• Up-to-date with vaccinations
• Hb >10 g/dL
• Breastfeeding with intent to continue for duration of study
• Negative blood slide for malaria
• Written informed consent

Exclusion criteria

• Acute malnutrition
• Current or anticipated used of infant formula or other fortified products
• Current or planned use of iron (or zinc) supplements
• Previous hospitalization for malaria within the last four weeks
• Persistent diarrhea

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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63 participants in 3 patient groups, including a placebo group

Micronutrient Powder (MNP) + Zn/Fe

Active Comparator group

Description:

Micronutrient Powder with 5 mg Zn and 12 mg Fe

Treatment:

Dietary Supplement: MNP + Zn/Fe

MNP + Zn

Active Comparator group

Description:

Micronutrient Powder with 5 mg Zn

Treatment:

Dietary Supplement: MNP + Zn

Control

Placebo Comparator group

Description:

Placebo sachets without micronutrients

Treatment:

Dietary Supplement: Placebo