NCT00705445

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 2,745 (actual)
• Sponsor: Aga Khan University · Academic / Other
• Sex: All
• Age: 2 Weeks – 6 Months
• Healthy volunteers: Accepted

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.

Conditions

• Malnutrition
• Diarrhea
• Pneumonia
• Growth

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-11-01
• Primary completion: 2011-06-01
• Completion: 2012-07-01
• First posted: 2008-06-26
• Last updated: 2012-08-28

Locations

2 sites across 1 country: Pakistan