Evaluation of Zinc and / or Micronutrient Supplementation on Intestinal Flora, Diarrheal Disease Burden, Intestinal Mucosal Integrity and Growth Among Children of Pakistan

Last updated: August 27, 2012
Sponsor: Aga Khan University
Overall Status: Completed

Phase

2/3

Condition

Bowel Dysfunction

Stomach Discomfort

Weight Loss

Treatment

N/A

Clinical Study ID

NCT00705445
752-Peds/ERC-07
  • Ages < 6
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Information on the mechanisms of zinc is still in developing phase. Ecological and biological implications of long term zinc supplementation at population level requires assessment. The trial aims to assess the impact of routine supplementation of zinc among young growing children and evaluate its impact on intestinal microbial flora and relationship with gut mucosa integrity and co-morbidities.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Children of ages 2 weeks to 6 months for recruitment into the Trial. Children of ages 6 months and onwards would eligible to receive intervention (in the form ofMicronutrient Sprinkles)

Exclusion

Exclusion Criteria:

  • Children with obvious congenital anomalies.

Study Design

Total Participants: 2745
Study Start date:
November 01, 2008
Estimated Completion Date:
July 31, 2012

Study Description

WHO has recommended the use of zinc for the treatment of acute diarrhea. Literature supports up-scaling of zinc supplementation programs to prevent childhood illnesses, such as diarrhea and respiratory infections, and its subsequent co-morbid conditions. As the potential mechanisms of action of zinc still remains to be established, this trial is proposed to evaluate the relationship of intestinal microbial flora, intestinal permeability, morbidity patterns and response to various enteric pathogens in a representative birth cohort randomly allocated to receive daily zinc and micronutrients from 6-18 months of age, and a control population.

Connect with a study center

  • The Aga Khan University

    Karachi, Sindh 75300
    Pakistan

    Site Not Available

  • Project Office, Matiari

    Matiari, Sindh 75300
    Pakistan

    Site Not Available

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