Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

June 25, 2008
August 27, 2012
November 2008
June 2011   (final data collection date for primary outcome measure)
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 ]
Episodes of Diarrhea and additional mobility such as acute lower respiratory tract infection, pneumonia and days with severe illness. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00705445 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Evaluation of Zinc and / or Micronutrient Supplementation on Intestinal Flora, Diarrheal Disease Burden, Intestinal Mucosal Integrity and Growth Among Children of Pakistan
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

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
  • Malnutrition
  • Diarrhea
  • Pneumonia
  • Growth
  • Dietary Supplement: Micronutrient Supplementation without Zinc
    This will contain Micronutrient Supplements containing Microencapsulated Iron, Vitamin C, Vitamin A, Vitamin D and Folic Acid
  • 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.
  • Other: Nutritional Counselling and Education
    This will contain Nutritional Counselling and Education.
  • 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.
    Intervention: Other: 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.

    Intervention: Dietary Supplement: Micronutrient Supplementation without Zinc
  • 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.

    Intervention: Dietary Supplement: Micronutrient Supplementation with Zinc

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2745
July 2012
June 2011   (final data collection date for primary outcome measure)

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.
Both
up to 6 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Pakistan
 
NCT00705445
752-Peds/ERC-07
Yes
Dr Zulfiqar Ahmed Bhutta, Aga Khan University
Aga Khan University
  • Bill and Melinda Gates Foundation
  • Tufts University
Principal Investigator: Zulfiqar ZB Bhutta, MBBS, PhD The Aga Khan University
Aga Khan University
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP