Exchangeable Zinc Pool Size and Zn Absorption From Sprinkles and Traditional Foods in Pakistani Infants /Toddlers

Completed

• Conditions: Malnutrition

• Registration Number: NCT01541696
• Lead Sponsor: Aga Khan University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2010-06
• Primary Completion: 2011-12
• Study First Submitted: 2012-01-11
• Study First Submitted QC: 2012-02-24
• Study First Posted: 2012-03-01
• Study Completion: 2012-06
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-02
• Last Update Posted: 2018-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Exchangeable Zn Pool Size and Zn Absorption from Sprinkles and Traditional Foods in Pakistani Infants/Toddlers	one year	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 ) .; Compare plasma zinc levels between the two groups Measure the fractional absorption of zinc between the two groups

Trial Locations

Locations (1)

Bilal Colony; 🇵🇰 Karachi, Sindh, Pakistan