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

NCT01541696 | Completed DMC

• 1 other identifier: 1387-PED-ERC-09
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Malnutrition

Keywords

zinc; zn; EZP (exchangeable zinc pools)multivitamin MN

Outcome Measures

Primary Outcomes (1)

• Exchangeable Zn Pool Size and Zn Absorption from Sprinkles and Traditional Foods in Pakistani Infants/Toddlers

  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

Study Arms (2)

Group B

subjects in this group will receive Micronutrient Supplements only.

Group C

Subjects in this Group will receive Micronutrient Supplements plus Zinc.

Eligibility Criteria

• Age: 9 Months - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Infants between the ages of 9 and 12 months

You may qualify if:

• 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 .

You may not qualify if:

• Infants with congenital anomalies
• Infants not on weaning diet
• Infants not consuming sprinkles sachet containing micronutrients

Sponsors & Collaborators

• Aga Khan University: lead
• University of Colorado, Denver: collaborator
• International Atomic Energy Agency: collaborator
• Bill and Melinda Gates Foundation: collaborator

Study Sites (1)

Bilal Colony

Karachi, Sindh, 75300, Pakistan

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Sajid B Soofi, MBBS, FCPS

  Aga Khan University

  PRINCIPAL INVESTIGATOR

• Shabina Ariff, MBBS, FCPS

  Aga Khan University

  STUDY DIRECTOR

• Zulfiqar A Bhutta, PhD

  Aga Khan University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 11, 2012
• First Posted: March 1, 2012
• Study Start: June 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: June 1, 2012
• Last Updated: June 6, 2018

Record last verified: 2018-06

Locations

PA (1)