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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Malnutrition, Diarrhea, Pneumonia, Growth

Intervention / Treatment
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* Dietary Supplement: Micronutrient Supplementation without Zinc
* Dietary Supplement: Micronutrient Supplementation with Zinc
* Other: Nutritional Counselling and Education


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Weeks
Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>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<br>* This will contain Nutritional Counselling and Education.<br>|
| Experimental: B<br>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<br>* This will contain Micronutrient Supplements containing Microencapsulated Iron, Vitamin C, Vitamin A, Vitamin D and Folic Acid<br>|
| Experimental: C<br>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<br>* This will contain Microencapsulated Iron, Vitamin C, Vitamin A, Vitamin D, and Folic Acid. Additionally, this will also contain 10 mg elemental Zinc Sulphate.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Episodes of Diarrhea and additional morbidity such as acute lower respiratory tract infection, pneumonia and days with severe illness. |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malnutrition, Diarrhea, Pneumonia, Growth, Zinc Supplements, Microbiome