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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Colorado, Denver
International Atomic Energy Agency
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Dr Shabina Ariff, Aga Khan University
ClinicalTrials.gov Identifier:
NCT01541696
First received: January 11, 2012
Last updated: March 6, 2012
Last verified: March 2012

January 11, 2012
March 6, 2012
June 2010
December 2011   (final data collection date for primary outcome measure)
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

Same as current
Complete list of historical versions of study NCT01541696 on ClinicalTrials.gov Archive Site
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Exchangeable Zinc 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

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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

Infants between the ages of 9 and 12 months

Malnutrition
Not Provided
  • Group B
    subjects in this group will receive Micronutrient Supplements only.
  • Group C
    Subjects in this Group will receive Micronutrient Supplements plus Zinc.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
June 2012
December 2011   (final data collection date for primary outcome measure)

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
Both
9 Months to 12 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Pakistan
 
NCT01541696
1387-PED-ERC-09
Yes
Dr Shabina Ariff, Aga Khan University
Aga Khan University
  • University of Colorado, Denver
  • International Atomic Energy Agency
  • Bill and Melinda Gates Foundation
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
Aga Khan University
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP