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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00705445
Recruitment Status : Completed
First Posted : June 26, 2008
Last Update Posted : August 28, 2012
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
Tufts University
Information provided by (Responsible Party):
Dr Zulfiqar Ahmed Bhutta, Aga Khan University

Study Description
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Brief 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.

Condition or disease Intervention/treatment 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

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2745 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : November 2008
Actual Primary Completion Date : June 2011
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Episodes of Diarrhea and additional morbidity such as acute lower respiratory tract infection, pneumonia and days with severe illness. [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   2 Weeks to 6 Months   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00705445


Locations
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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
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Principal Investigator: Zulfiqar ZB Bhutta, MBBS, PhD The Aga Khan University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr Zulfiqar Ahmed Bhutta, Professor and Founding Chair, Division of Women and Child Health, Aga Khan University
ClinicalTrials.gov Identifier: NCT00705445    
Other Study ID Numbers: 752-Peds/ERC-07
First Posted: June 26, 2008    Key Record Dates
Last Update Posted: August 28, 2012
Last Verified: August 2012
Keywords provided by Dr Zulfiqar Ahmed Bhutta, Aga Khan University:
Malnutrition
Diarrhea
Pneumonia
 Growth
Zinc Supplements
Microbiome
Additional relevant MeSH terms:
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Pneumonia
Malnutrition
Diarrhea
Respiratory Tract Infections
Infections
Lung Diseases
Respiratory Tract Diseases
 Signs and Symptoms, Digestive
Nutrition Disorders
Zinc
Trace Elements
Micronutrients
Physiological Effects of Drugs