Evaluation of Zinc and / or Micronutrient Supplementation on Intestinal Flora, Diarrheal Disease Burden, Intestinal Mucosal Integrity and Growth Among Children of Pakistan
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|ClinicalTrials.gov Identifier: NCT00705445|
Recruitment Status : Completed
First Posted : June 26, 2008
Last Update Posted : August 28, 2012
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|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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2745 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|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|
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.
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
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.
- Episodes of Diarrhea and additional morbidity such as acute lower respiratory tract infection, pneumonia and days with severe illness. [ Time Frame: 2 years ]
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|Ages Eligible for Study:||2 Weeks to 6 Months (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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)
- Children with obvious congenital anomalies.
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
|The Aga Khan University|
|Karachi, Sindh, Pakistan, 75300|
|Project Office, Matiari|
|Matiari, Sindh, Pakistan, 75300|
|Principal Investigator:||Zulfiqar ZB Bhutta, MBBS, PhD||The Aga Khan University|
|Responsible Party:||Dr Zulfiqar Ahmed Bhutta, Professor and Founding Chair, Division of Women and Child Health, Aga Khan University|
|Other Study ID Numbers:||
|First Posted:||June 26, 2008 Key Record Dates|
|Last Update Posted:||August 28, 2012|
|Last Verified:||August 2012|
Respiratory Tract Infections
Respiratory Tract Diseases
Signs and Symptoms, Digestive
Physiological Effects of Drugs