Clinical trial NCT01541696: Exchangeable Zinc Pool Size and Zn Absorption From Sprinkles and Traditional Foods in Pakistani Infants /Toddlers
Official title: Exchangeable Zn Pool Size and Zn Absorption From Sprinkles and Traditional Foods in Pakistani Infants/Toddlers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malnutrition
Keywords: zinc
zn
EZP (exchangeable zinc pools)multivitamin MN
Lead sponsor: Aga Khan University
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
name: International Atomic Energy Agency
name: Bill and Melinda Gates Foundation
First posted: 2012-03-01
Enrollment: 40
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infants between the ages of 9 and 12 months

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.

Eligibility criteria: 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

Primary outcomes:
measure: Exchangeable Zn Pool Size and Zn Absorption from Sprinkles and Traditional Foods in Pakistani Infants/Toddlers
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Bilal Colony
state: Sindh
Study officials:
affiliation: Aga Khan University
name: Sajid B Soofi, MBBS, FCPS
role: PRINCIPAL_INVESTIGATOR
affiliation: Aga Khan University
name: Shabina Ariff, MBBS, FCPS
role: STUDY_DIRECTOR
affiliation: Aga Khan University
name: Zulfiqar A Bhutta, PhD
role: STUDY_CHAIR
References: