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Completed

NCT Number: NCT00705445

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

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.

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Key information

Conditions

Malnutrition Diarrhea Growth Infections Lung Diseases Nutrition Disorders Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Pneumonia Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Digestive

Age range

2 week–6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

The Aga Khan University, Karachi, Sindh, Pakistan

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 of Micronutrient Sprinkles)

Exclusion criteria

  • Children with obvious congenital anomalies.

Treatment and study plan

Micronutrient Supplementation without Zinc

Dietary Supplement

This will contain Micronutrient Supplements containing Microencapsulated Iron, Vitamin C, Vitamin A, Vitamin D and Folic Acid

Micronutrient Supplementation with Zinc

Dietary Supplement

This will contain Microencapsulated Iron, Vitamin C, Vitamin A, Vitamin D, and Folic Acid. Additionally, this will also contain 10 mg elemental Zinc Sulphate.

Nutritional Counselling and Education

Other

This will contain Nutritional Counselling and Education.

Primary outcomes

  1. Episodes of Diarrhea and additional morbidity such as acute lower respiratory tract infection, pneumonia and days with severe illness.

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Collaborators

  • Bill and Melinda Gates Foundation
  • Tufts University

Registry information

Official study title

Prospective Cluster Randomized Controlled Evaluation of the Impact of Zinc and / or Micronutrient Supplementation on Intestinal Flora, Diarrheal Disease Burden, Intestinal Mucosal Integrity and Growth Among Cohorts of Children in Pakistan

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
Jun 26, 2008
Registry last updated
Aug 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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