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| Name | Class |
|---|---|
| Bill and Melinda Gates Foundation | OTHER |
| Tufts University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | 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. |
|
| B | Experimental | 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. |
|
| C | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Micronutrient Supplementation without Zinc | Dietary Supplement | This will contain Micronutrient Supplements containing Microencapsulated Iron, Vitamin C, Vitamin A, Vitamin D and Folic Acid |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zulfiqar ZB Bhutta, MBBS, PhD | Aga Khan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Aga Khan University | Karachi | Sindh | 75300 | Pakistan | ||
| Project Office, Matiari |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36904212 | Derived | Balaji V, Dinh DM, Kane AV, Soofi S, Ahmed I, Rizvi A, Chatterjee M, Babji S, Duara J, Moy J, Naumova EN, Wanke CA, Ward HD, Bhutta ZA. Longitudinal Analysis of the Intestinal Microbiota among a Cohort of Children in Rural and Urban Areas of Pakistan. Nutrients. 2023 Feb 28;15(5):1213. doi: 10.3390/nu15051213. | |
| 34795270 | Derived |
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| Micronutrient Supplementation with Zinc | Dietary Supplement | This will contain Microencapsulated Iron, Vitamin C, Vitamin A, Vitamin D, and Folic Acid. Additionally, this will also contain 10 mg elemental Zinc Sulphate. |
|
| Nutritional Counselling and Education | Other | This will contain Nutritional Counselling and Education. |
|
| Matiari |
| Sindh |
| 75300 |
| Pakistan |
| Popovic A, Bourdon C, Wang PW, Guttman DS, Soofi S, Bhutta ZA, Bandsma RHJ, Parkinson J, Pell LG. Micronutrient supplements can promote disruptive protozoan and fungal communities in the developing infant gut. Nat Commun. 2021 Nov 18;12(1):6729. doi: 10.1038/s41467-021-27010-3. |
| 24225451 | Derived | Ariff S, Krebs NF, Soofi S, Westcott J, Bhatti Z, Tabassum F, Bhutta ZA. Absorbed zinc and exchangeable zinc pool size are greater in Pakistani infants receiving traditional complementary foods with zinc-fortified micronutrient powder. J Nutr. 2014 Jan;144(1):20-6. doi: 10.3945/jn.113.178715. Epub 2013 Nov 13. |
| 23602230 | Derived | Soofi S, Cousens S, Iqbal SP, Akhund T, Khan J, Ahmed I, Zaidi AK, Bhutta ZA. Effect of provision of daily zinc and iron with several micronutrients on growth and morbidity among young children in Pakistan: a cluster-randomised trial. Lancet. 2013 Jul 6;382(9886):29-40. doi: 10.1016/S0140-6736(13)60437-7. Epub 2013 Apr 18. |
| ID | Term |
|---|---|
| D044342 | Malnutrition |
| D003967 | Diarrhea |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D015032 | Zinc |
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
| D008670 | Metals |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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