A Trial of Zinc and Micronutrients in Tanzanian Children
NCT ID: NCT00421668
Last Updated: 2017-03-03
Study Results
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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COMPLETED
PHASE3
2400 participants
INTERVENTIONAL
2007-09-30
2012-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
QUADRUPLE
Study Groups
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Multivitamins
Vitamins C, E, B1, B2, niacin, B6, folate, and B12
Multivitamins
Vitamins C, E, B1, B2, niacin, B6, folate and B12
Multivitamins + Zinc
Vitamins C, E, B1, B2, niacin, B6, folate and B12, and zinc
Zinc
zinc
Multivitamins
Vitamins C, E, B1, B2, niacin, B6, folate and B12
Zinc
zinc
Zinc
zinc
Placebo
placebo
Placebo
Placebo
Interventions
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Zinc
zinc
Multivitamins
Vitamins C, E, B1, B2, niacin, B6, folate and B12
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
6 Weeks
18 Months
ALL
Yes
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Harvard School of Public Health (HSPH)
OTHER
Responsible Party
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Christopher Duggan
Professor of Nutrition
Principal Investigators
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Christopher P Duggan, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Harvard School of Public Health (HSPH)
Locations
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Muhimbili Uinverstiy College of Health Sciences
Dar es Salaam, , Tanzania
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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HD048969
Identifier Type: -
Identifier Source: org_study_id
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