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

NCT ID: NCT00705445

Last Updated: 2012-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

2745 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2012-07-31

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.

Conditions

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Malnutrition Diarrhea Pneumonia Growth

Keywords

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Malnutrition Diarrhea Pneumonia Growth Zinc Supplements Microbiome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Nutritional Counselling and Education

Intervention Type OTHER

This will contain Nutritional Counselling and Education.

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.

Group Type EXPERIMENTAL

Micronutrient Supplementation without Zinc

Intervention Type DIETARY_SUPPLEMENT

This will contain Micronutrient Supplements containing Microencapsulated Iron, Vitamin C, Vitamin A, Vitamin D and Folic Acid

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.

Group Type EXPERIMENTAL

Micronutrient Supplementation with Zinc

Intervention Type 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.

Interventions

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Micronutrient Supplementation without Zinc

This will contain Micronutrient Supplements containing Microencapsulated Iron, Vitamin C, Vitamin A, Vitamin D and Folic Acid

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Nutritional Counselling and Education

This will contain Nutritional Counselling and Education.

Intervention Type OTHER

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.
Minimum Eligible Age

2 Weeks

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bill and Melinda Gates Foundation

OTHER

Sponsor Role collaborator

Tufts University

OTHER

Sponsor Role collaborator

Aga Khan University

OTHER

Sponsor Role lead

Responsible Party

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Dr Zulfiqar Ahmed Bhutta

Professor and Founding Chair, Division of Women and Child Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zulfiqar ZB Bhutta, MBBS, PhD

Role: PRINCIPAL_INVESTIGATOR

Aga Khan University

Locations

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The Aga Khan University

Karachi, Sindh, Pakistan

Site Status

Project Office, Matiari

Matiari, Sindh, Pakistan

Site Status

Countries

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Pakistan

References

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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.

Reference Type DERIVED
PMID: 36904212 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34795270 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24225451 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23602230 (View on PubMed)

Other Identifiers

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752-Peds/ERC-07

Identifier Type: -

Identifier Source: org_study_id