Exchangeable Zinc Pool Size and Zn Absorption From Sprinkles and Traditional Foods in Pakistani Infants /Toddlers
Recruitment status was Active, not recruiting
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Exchangeable Zn Pool Size and Zn Absorption From Sprinkles and Traditional Foods in Pakistani Infants/Toddlers|
- Exchangeable Zn Pool Size and Zn Absorption from Sprinkles and Traditional Foods in Pakistani Infants/Toddlers [ Time Frame: one year ] [ Designated as safety issue: No ]
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
|Study Start Date:||June 2010|
|Estimated Study Completion Date:||June 2012|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
subjects in this group will receive Micronutrient Supplements only.
Subjects in this Group will receive Micronutrient Supplements plus Zinc.
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 :
- 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.
- 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.
- Children will be followed for growth monitoring for at least 2 years.
- Plasma zinc and phytates levels in the weaning diet will also be assessed.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01541696
|Karachi, Sindh, Pakistan, 75300|
|Principal Investigator:||Sajid B Soofi, MBBS, FCPS||The Aga Khan University|
|Study Director:||Shabina Ariff, MBBS, FCPS||The Aga Khan University|
|Study Chair:||Zulfiqar A Bhutta, PhD||The Aga Khan University|