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

June 2, 2018 updated by: Dr Shabina Ariff, Aga Khan University

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 75300
        • Bilal Colony

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 months to 1 year (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Infants between the ages of 9 and 12 months

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Group B
subjects in this group will receive Micronutrient Supplements only.
Group C
Subjects in this Group will receive Micronutrient Supplements plus Zinc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aga Khan University

Collaborators

University of Colorado, Denver
Bill and Melinda Gates Foundation
International Atomic Energy Agency

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

January 11, 2012

First Submitted That Met QC Criteria

February 24, 2012

First Posted (Estimate)

March 1, 2012

Study Record Updates

Last Update Posted (Actual)

June 6, 2018

Last Update Submitted That Met QC Criteria

June 2, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1387-PED-ERC-09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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