Overview

This trial is active, not recruiting.

Condition malnutrition
Sponsor Aga Khan University
Collaborator University of Colorado, Denver
Start date June 2010
End date December 2011
Trial size 40 participants
Trial identifier NCT01541696, 1387-PED-ERC-09

Summary

The broad objective is to improve zinc status in older infants and young children who are at risk of zinc deficiency because of combination of inadequate dietary zinc intake and high rates of diarrhea. As a sub-study within larger RCT using zinc fortified Sprinkles, the proposed study will measure the amount of zinc absorbed from a test meal of typical unfortified complementary foods consumed by Pakistani infants, or the same complementary foods fortified by the addition of the Zn-containing Sprinkle.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
subjects in this group will receive Micronutrient Supplements only.
Subjects in this Group will receive Micronutrient Supplements plus Zinc.

Primary Outcomes

Measure
Exchangeable Zn Pool Size and Zn Absorption from Sprinkles and Traditional Foods in Pakistani Infants/Toddlers
time frame: one year

Eligibility Criteria

Male or female participants from 9 months up to 12 months old.

Inclusion Criteria: - Healthy Infants between the ages of 9 and 12 months and on weaning diet for at least 3 months. - Infants who are currently recruited in the main zinc gates study and consuming sprinkles sachet containing micronutrient and zinc . Exclusion Criteria: - Infants with congenital anomalies - Infants not on weaning diet - Infants not consuming sprinkles sachet containing micronutrients

Additional Information

Official title Exchangeable Zn Pool Size and Zn Absorption From Sprinkles and Traditional Foods in Pakistani Infants/Toddlers
Principal investigator Sajid B Soofi, MBBS, FCPS
Description In the nested study we aim to measure from a subgroup of recruited children in the main study, the amount of zinc absorbed from typical unfortified complementary foods consumed by Pakistani infants, and compare it with the same complementary food fortified by the addition of the Zn-containing Sprinkles and multi vitamins. Since EZP Exchangeable Zinc Pool is considered to be the gold standard for estimation of the actual concentration of zinc in the plasma that is readily available for cellular function, we would also calculate the EZP in this subset of samples. The specific aim of the nested study will : 1. Determine absorption of zinc (Zn) from a test meal consisting of typical local food with addition of a multiple-micronutrient Sprinkles product containing (10 mg of Zn) vs absorption from the same meal without zinc supplementation to those with no micronutrient fortification. 2. Compare size of exchangeable Zn pool (EZP) for subjects who have been randomized to receive multi-micronutrient Sprinkle (MN) only with those who were randomized to (MN+Zn ) with control group. 3. Children will be followed for growth monitoring for at least 2 years. 4. Plasma zinc and phytates levels in the weaning diet will also be assessed.
Trial information was received from ClinicalTrials.gov and was last updated in March 2012.
Information provided to ClinicalTrials.gov by Aga Khan University.