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

NCT00705445 | Completed Phase 2 DMC

• 1 other identifier: 752-Peds/ERC-07
• Study Type: interventional
• Target: 2,745
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Malnutrition; Diarrhea; Pneumonia; Growth

Keywords

Malnutrition; Diarrhea; Pneumonia; Growth; Zinc Supplements; Microbiome

Outcome Measures

Primary Outcomes (1)

• Episodes of Diarrhea and additional morbidity such as acute lower respiratory tract infection, pneumonia and days with severe illness.

  2 years

Study Arms (3)

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.

Other: Nutritional Counselling and Education

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.

Dietary Supplement: Micronutrient Supplementation without Zinc

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.

Dietary Supplement: Micronutrient Supplementation with Zinc

Interventions

Micronutrient Supplementation without Zinc DIETARY_SUPPLEMENT

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

B

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.

C

Nutritional Counselling and Education OTHER

This will contain Nutritional Counselling and Education.

A

Eligibility Criteria

• Age: 2 Weeks - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• Children with obvious congenital anomalies.

Sponsors & Collaborators

• Aga Khan University: lead
• Bill and Melinda Gates Foundation: collaborator
• Tufts University: collaborator

Study Sites (2)

The Aga Khan University

Karachi, Sindh, 75300, Pakistan

Location

Project Office, Matiari

Matiari, Sindh, 75300, Pakistan

Location

Related Publications (4)

• 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.

  PMID: 36904212 DERIVED

• 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.

  PMID: 34795270 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.

  PMID: 24225451 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.

  PMID: 23602230 DERIVED

MeSH Terms

Conditions

Malnutrition; Diarrhea; Pneumonia

Interventions

Zinc; Educational Status

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Socioeconomic Factors; Population Characteristics

Study Officials

• Zulfiqar ZB Bhutta, MBBS, PhD

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Founding Chair, Division of Women and Child Health

Study Record Dates

• First Submitted: June 25, 2008
• First Posted: June 26, 2008
• Study Start: November 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: July 1, 2012
• Last Updated: August 28, 2012

Record last verified: 2012-08

Locations

PA (2)