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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by Dr Shabina Ariff, Aga Khan University.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01541696
First Posted: March 1, 2012
Last Update Posted: March 7, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  Purpose
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.

Condition
Malnutrition

Study Type: Observational
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

Further study details as provided by Dr Shabina Ariff, Aga Khan University:

Primary Outcome Measures:
  • Exchangeable Zn Pool Size and Zn Absorption from Sprinkles and Traditional Foods in Pakistani Infants/Toddlers [ Time Frame: 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



Enrollment: 40
Study Start Date: June 2010
Estimated Study Completion Date: June 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group B
subjects in this group will receive Micronutrient Supplements only.
Group C
Subjects in this Group will receive Micronutrient Supplements plus Zinc.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   9 Months to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Infants between the ages of 9 and 12 months
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01541696


Locations
Pakistan
Bilal Colony
Karachi, Sindh, Pakistan, 75300
Sponsors and Collaborators
Aga Khan University
University of Colorado, Denver
International Atomic Energy Agency
Bill and Melinda Gates Foundation
Investigators
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
  More Information

Responsible Party: Dr Shabina Ariff, Assistant Professor, Aga Khan University
ClinicalTrials.gov Identifier: NCT01541696     History of Changes
Other Study ID Numbers: 1387-PED-ERC-09
First Submitted: January 11, 2012
First Posted: March 1, 2012
Last Update Posted: March 7, 2012
Last Verified: March 2012

Keywords provided by Dr Shabina Ariff, Aga Khan University:
zinc
zn
EZP (exchangeable zinc pools)multivitamin MN

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders