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

Malnutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01541696
• Other study ID #: 1387-PED-ERC-09
• Status: Completed
• Start date: June 2010
• Est. completion date: June 2012

Study information

• Verified date: June 2018
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Months to 12 Months

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition

Locations

Country	Name	City	State
Pakistan	Bilal Colony	Karachi	Sindh

Sponsors (4)

Lead Sponsor	Collaborator
Aga Khan University	Bill and Melinda Gates Foundation, International Atomic Energy Agency, University of Colorado, Denver

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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