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

This study has been completed.
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
Tufts University
Information provided by (Responsible Party):
Dr Zulfiqar Ahmed Bhutta, Aga Khan University
ClinicalTrials.gov Identifier:
NCT00705445
First received: June 25, 2008
Last updated: August 27, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Malnutrition
Diarrhea
Pneumonia
Growth
 Dietary Supplement: Micronutrient Supplementation without Zinc
Dietary Supplement: Micronutrient Supplementation with Zinc
Other: Nutritional Counselling and Education
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Aga Khan University:

Primary Outcome Measures:
  • Episodes of Diarrhea and additional morbidity such as acute lower respiratory tract infection, pneumonia and days with severe illness. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 2745
Study Start Date: November 2008
Study Completion Date: July 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
This group will not receive any of the intervention supplements. The group will only receive nutritional counselling and education, and treatment provided for any encountered illness according to IMCI guidelines.
 Other: Nutritional Counselling and Education
This will contain Nutritional Counselling and Education.
Experimental: B

This group will receive micronutrient supplements containing microencapsulated Iron, Vitamin C, Vitamin A, Vitamin D, and Folic Acid.

This group will also receive Nutritional Counselling and Education and treatment according to IMCI Guidelines for any serious illness.

 Dietary Supplement: Micronutrient Supplementation without Zinc
This will contain Micronutrient Supplements containing Microencapsulated Iron, Vitamin C, Vitamin A, Vitamin D and Folic Acid
Experimental: C

This group will receive Micronutrient Supplements containing Microencapsulated Iron, Vitamin C, Vitamin A, Vitamin D, Folic Acid, and Zinc.

This group will also receive nutritional counselling, education and treatment according to IMCI Guidelines in case of any untoward illness.

 Dietary Supplement: Micronutrient Supplementation with Zinc
This will contain Microencapsulated Iron, Vitamin C, Vitamin A, Vitamin D, and Folic Acid. Additionally, this will also contain 10 mg elemental Zinc Sulphate.

Detailed 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.

  Eligibility

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00705445

Locations
Pakistan
The Aga Khan University
Karachi, Sindh, Pakistan, 75300
Project Office, Matiari
Matiari, Sindh, Pakistan, 75300
Sponsors and Collaborators
Aga Khan University
Bill and Melinda Gates Foundation
Tufts University
Investigators
Principal Investigator: Zulfiqar ZB Bhutta, MBBS, PhD The Aga Khan University
  More Information

No publications provided

Responsible Party: Dr Zulfiqar Ahmed Bhutta, Professor and Founding Chair, Division of Women and Child Health, Aga Khan University
ClinicalTrials.gov Identifier: NCT00705445     History of Changes
Other Study ID Numbers: 752-Peds/ERC-07
Study First Received: June 25, 2008
Last Updated: August 27, 2012
Health Authority: Pakistan: Ministry of Health

Keywords provided by Aga Khan University:
Malnutrition
Diarrhea
Pneumonia
 Growth
Zinc Supplements
Microbiome

Additional relevant MeSH terms:
Diarrhea
Pneumonia
Malnutrition
Signs and Symptoms, Digestive
Signs and Symptoms
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
 Nutrition Disorders
Micronutrients
Zinc
Trace Elements
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013