A Trial of Zinc and Micronutrients in Tanzanian Children

NCT00421668 | Completed Phase 3 DMC

• 1 other identifier: HD048969
• Study Type: interventional
• Target: 2,400
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized clinical trial of multiple micronutrients, zinc, zinc + micronutrients, or placebo among 2400 children born to HIV-negative Tanzanian mothers.

Conditions

Diarrheal Illnesses; Respiratory Illness; Growth Faltering

Keywords

HIV; Tanzania; Micronutrients; Infants/children; Infectious Disease; Growth faltering

Outcome Measures

Primary Outcomes (2)

• Incidence of diarrhea

  from ages 6 weeks to 18 months

• respiratory tract infections

  from ages 6 weeks to 18 months

Secondary Outcomes (2)

• Weight gain

  from age 6 weeks to 18 months

• Length/height gain

  from age 6 weeks to 18 months

Study Arms (4)

Multivitamins

EXPERIMENTAL

Vitamins C, E, B1, B2, niacin, B6, folate, and B12

Drug: Multivitamins

Multivitamins + Zinc

EXPERIMENTAL

Vitamins C, E, B1, B2, niacin, B6, folate and B12, and zinc

Drug: Zinc; Drug: Multivitamins

Zinc

EXPERIMENTAL

zinc

Drug: Zinc

Placebo

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

Zinc DRUG

zinc

Multivitamins + Zinc; Zinc

Multivitamins DRUG

Vitamins C, E, B1, B2, niacin, B6, folate and B12

Multivitamins; Multivitamins + Zinc

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 6 Weeks - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Singleton, live born infants born to HIV- negative women
• Mothers will need to have registered for pre-natal care before 34 weeks gestation
• intend to stay in Dar es Salaam for until delivery and 18 months thereafter.

You may not qualify if:

• infants born with multiple congenital abnormalities

Sponsors & Collaborators

• Harvard School of Public Health (HSPH): lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Muhimbili Uinverstiy College of Health Sciences

Dar es Salaam, Tanzania

Location

Related Publications (12)

• Liu E, Manji KP, Kirby MA, Kisenge R, Lauer JM, Fawzi WW, Sudfeld CR, Duggan CP. Effects of Zinc Supplementation on Metabolomic Profiles in Tanzanian Infants: A Randomized Trial. J Nutr. 2024 Feb;154(2):403-411. doi: 10.1016/j.tjnut.2023.12.011. Epub 2023 Dec 11.

  PMID: 38092153 DERIVED

• Rees CA, Kisenge R, Manji KP, Liu E, Fawzi WW, Duggan CP. Identifying Infants and Young Children at Risk of Unplanned Hospital Admissions and Clinic Visits in Dar es Salaam, Tanzania. Pediatr Infect Dis J. 2020 Dec;39(12):e428-e434. doi: 10.1097/INF.0000000000002875.

  PMID: 32842043 DERIVED

• Lauer JM, McDonald CM, Kisenge R, Aboud S, Fawzi WW, Liu E, Tran HQ, Gewirtz AT, Manji KP, Duggan CP. Markers of Systemic Inflammation and Environmental Enteric Dysfunction Are Not Reduced by Zinc or Multivitamins in Tanzanian Infants: A Randomized, Placebo-Controlled Trial. J Pediatr. 2019 Jul;210:34-40.e1. doi: 10.1016/j.jpeds.2019.02.016. Epub 2019 Apr 2.

  PMID: 30952509 DERIVED

• Blakstad MM, Smith ER, Etheredge A, Locks LM, McDonald CM, Kupka R, Kisenge R, Aboud S, Bellinger D, Sudfeld CR, Fawzi WW, Manji K, Duggan CP. Nutritional, Socioeconomic, and Delivery Characteristics Are Associated with Neurodevelopment in Tanzanian Children. J Pediatr. 2019 Apr;207:71-79.e8. doi: 10.1016/j.jpeds.2018.10.066. Epub 2018 Dec 14.

  PMID: 30559023 DERIVED

• Etheredge AJ, Manji K, Kellogg M, Tran H, Liu E, McDonald CM, Kisenge R, Aboud S, Fawzi W, Bellinger D, Gewirtz AT, Duggan CP. Markers of Environmental Enteric Dysfunction Are Associated With Neurodevelopmental Outcomes in Tanzanian Children. J Pediatr Gastroenterol Nutr. 2018 Jun;66(6):953-959. doi: 10.1097/MPG.0000000000001978.

  PMID: 29613921 DERIVED

• Winje BA, Kvestad I, Krishnamachari S, Manji K, Taneja S, Bellinger DC, Bhandari N, Bisht S, Darling AM, Duggan CP, Fawzi W, Hysing M, Kumar T, Kurpad AV, Sudfeld CR, Svensen E, Thomas S, Strand TA. Does early vitamin B12 supplementation improve neurodevelopment and cognitive function in childhood and into school age: a study protocol for extended follow-ups from randomised controlled trials in India and Tanzania. BMJ Open. 2018 Feb 22;8(2):e018962. doi: 10.1136/bmjopen-2017-018962.

  PMID: 29472265 DERIVED

• Locks LM, Mwiru RS, Mtisi E, Manji KP, McDonald CM, Liu E, Kupka R, Kisenge R, Aboud S, Gosselin K, Gillman M, Gewirtz AT, Fawzi WW, Duggan CP. Infant Nutritional Status and Markers of Environmental Enteric Dysfunction are Associated with Midchildhood Anthropometry and Blood Pressure in Tanzania. J Pediatr. 2017 Aug;187:225-233.e1. doi: 10.1016/j.jpeds.2017.04.005. Epub 2017 May 9.

  PMID: 28499715 DERIVED

• Locks LM, Manji KP, Kupka R, Liu E, Kisenge R, McDonald CM, Aboud S, Wang M, Fawzi WW, Duggan CP. High Burden of Morbidity and Mortality but Not Growth Failure in Infants Exposed to but Uninfected with Human Immunodeficiency Virus in Tanzania. J Pediatr. 2017 Jan;180:191-199.e2. doi: 10.1016/j.jpeds.2016.09.040. Epub 2016 Nov 7.

  PMID: 27829511 DERIVED

• Locks LM, Manji KP, McDonald CM, Kupka R, Kisenge R, Aboud S, Wang M, Bellinger DC, Fawzi WW, Duggan CP. The effect of daily zinc and/or multivitamin supplements on early childhood development in Tanzania: results from a randomized controlled trial. Matern Child Nutr. 2017 Apr;13(2):e12306. doi: 10.1111/mcn.12306. Epub 2016 May 18.

  PMID: 27189038 DERIVED

• McDonald CM, Manji KP, Gosselin K, Tran H, Liu E, Kisenge R, Aboud S, Fawzi WW, Gewirtz AT, Duggan CP. Elevations in serum anti-flagellin and anti-LPS Igs are related to growth faltering in young Tanzanian children. Am J Clin Nutr. 2016 Jun;103(6):1548-54. doi: 10.3945/ajcn.116.131409. Epub 2016 Apr 27.

  PMID: 27121948 DERIVED

• Locks LM, Manji KP, McDonald CM, Kupka R, Kisenge R, Aboud S, Wang M, Fawzi WW, Duggan CP. Effect of zinc and multivitamin supplementation on the growth of Tanzanian children aged 6-84 wk: a randomized, placebo-controlled, double-blind trial. Am J Clin Nutr. 2016 Mar;103(3):910-8. doi: 10.3945/ajcn.115.120055. Epub 2016 Jan 27.

  PMID: 26817503 DERIVED

• McDonald CM, Manji KP, Kisenge R, Aboud S, Spiegelman D, Fawzi WW, Duggan CP. Daily Zinc but Not Multivitamin Supplementation Reduces Diarrhea and Upper Respiratory Infections in Tanzanian Infants: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. J Nutr. 2015 Sep;145(9):2153-60. doi: 10.3945/jn.115.212308. Epub 2015 Jul 22.

  PMID: 26203094 DERIVED

MeSH Terms

Conditions

Communicable Diseases

Interventions

Zinc; Geritol

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Christopher P Duggan, MD, MPH

  Harvard School of Public Health (HSPH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Nutrition

Study Record Dates

• First Submitted: January 11, 2007
• First Posted: January 12, 2007
• Study Start: September 1, 2007
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: March 3, 2017

Record last verified: 2017-03

Locations

TA (1)