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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Aga Khan University
- Enrollment
- 2,745
- Locations
- 2
- Primary Endpoint
- Episodes of Diarrhea and additional morbidity such as acute lower respiratory tract infection, pneumonia and days with severe illness.
Study Overview
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.
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 2 Weeks to 6 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
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: Nutritional Counselling and Education (Other)
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: Micronutrient Supplementation without Zinc (Dietary Supplement)
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: Micronutrient Supplementation with Zinc (Dietary Supplement)
Outcomes
Primary Outcomes
Episodes of Diarrhea and additional morbidity such as acute lower respiratory tract infection, pneumonia and days with severe illness.
Time Frame: 2 years
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr Zulfiqar Ahmed Bhutta
Professor and Founding Chair, Division of Women and Child Health
Aga Khan University