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Trial of Vitamins Among Children of HIV-infected Women

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00197730
First Posted: September 20, 2005
Last Update Posted: August 21, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Muhimbili University of Health and Allied Sciences
Information provided by:
Harvard School of Public Health
  Purpose
The purpose of this study is to examine the effects of multivitamin (B, C, E) supplementation on reducing the risk of morbidity and mortality outcomes among children born to HIV positive mothers, compared to placebo supplementation.

Condition Intervention Phase
HIV Infections Pregnancy Complications Drug: Multivitamins - vitamins B complex, C and E Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Trial of Vitamins Among Children of HIV-infected Women

Resource links provided by NLM:


Further study details as provided by Harvard School of Public Health:

Primary Outcome Measures:
  • All-cause mortality and diarrheal morbidity [ Time Frame: age 6 weeks to age 24 months ]

Secondary Outcome Measures:
  • Child growth faltering, lower respiratory infections, HIV breastfeeding transmission, and maternal HIV disease progression in relation to breastfeeding [ Time Frame: age 6 weeks to 24 months post partum ]

Enrollment: 2387
Study Start Date: June 2004
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Multivitamins
Vitamin E, Vitamin C, and Vitamin B complex
Drug: Multivitamins - vitamins B complex, C and E
Age-appropriate dosages of vitamin C, vitamin E, thiamine, riboflavin, niacin, vitamin B6, folate, and vitamin B12 administered orally to children aged 6 weeks to 6 months, and two capsules per day for children aged older than 6 months for at least 12 months
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo capsules administered orally once day orally to children aged 6 weeks to 6 months, and twice per day for children aged older than 6 months

Detailed Description:
An increasing body of evidence supports the efficacy of single and, more recently, multiple micronutrient supplementation in reducing morbidity and mortality in susceptible populations. For example, we recently completed a multiple micronutrient supplementation trial in HIV-positive Tanzanian women that showed a significant reduction in pre-term birth, fetal loss, and low birthweight. In children, we and others have also demonstrated the beneficial effects of vitamin A supplementation in reducing diarrheal disease and mortality. Our next priority is to evaluate the efficacy of multiple micronutrient supplementation in susceptible children. Children born to HIV-infected women are at risk of multiple micronutrient deficiencies due to poor dietary intake, malabsorption, and increased metabolic needs. In addition, these children, if HIV-infected themselves, are at significantly higher risk of death due to infectious illnesses compared to their non-infected peers. In this study, we propose to study the efficacy of micronutrient supplementation in reducing the risk of morbidity and mortality outcomes among children born to HIV positive mothers, compared to placebo supplementation.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Weeks to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Inclusion Criteria: Singleton, live born infants born to HIV-infected women Exclusion Criteria: Infants with multiple congenital abnormalities
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00197730


Locations
Tanzania
Muhimbili University of Health and Allied Sciences
Dar es Salaam, Tanzania
Sponsors and Collaborators
Harvard School of Public Health
Muhimbili University of Health and Allied Sciences
Investigators
Principal Investigator: Wafaie W Fawzi, MD, DrPH Harvard School of Public Health
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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.
Sztam KA, Liu E, Manji KP, Kupka R, Kisenge R, Aboud S, Fawzi WW, Bosch RJ, Duggan CP. Maternal Antiretroviral Therapy Is Associated with Lower Risk of Diarrhea in Early Childhood. J Pediatr. 2016 Aug;175:54-60. doi: 10.1016/j.jpeds.2016.04.088. Epub 2016 May 28.
Sudfeld CR, Duggan C, Aboud S, Kupka R, Manji KP, Kisenge R, Fawzi WW. Vitamin D status is associated with mortality, morbidity, and growth failure among a prospective cohort of HIV-infected and HIV-exposed Tanzanian infants. J Nutr. 2015 Jan;145(1):121-7. doi: 10.3945/jn.114.201566. Epub 2014 Nov 12.
Sudfeld CR, Duggan C, Histed A, Manji KP, Meydani SN, Aboud S, Wang M, Giovannucci EL, Fawzi WW. Effect of multivitamin supplementation on measles vaccine response among HIV-exposed uninfected Tanzanian infants. Clin Vaccine Immunol. 2013 Aug;20(8):1123-32. doi: 10.1128/CVI.00183-13. Epub 2013 May 29.
Kupka R, Manji KP, Bosch RJ, Aboud S, Kisenge R, Okuma J, Fawzi WW, Duggan C. Multivitamin supplements have no effect on growth of Tanzanian children born to HIV-infected mothers. J Nutr. 2013 May;143(5):722-7. doi: 10.3945/jn.112.170498. Epub 2013 Mar 20.
Duggan C, Manji KP, Kupka R, Bosch RJ, Aboud S, Kisenge R, Okuma J, Fawzi WW. Multiple micronutrient supplementation in Tanzanian infants born to HIV-infected mothers: a randomized, double-blind, placebo-controlled clinical trial. Am J Clin Nutr. 2012 Dec;96(6):1437-46. doi: 10.3945/ajcn.112.044263. Epub 2012 Nov 7.
McDonald CM, Kupka R, Manji KP, Okuma J, Bosch RJ, Aboud S, Kisenge R, Spiegelman D, Fawzi WW, Duggan CP. Predictors of stunting, wasting and underweight among Tanzanian children born to HIV-infected women. Eur J Clin Nutr. 2012 Nov;66(11):1265-76. doi: 10.1038/ejcn.2012.136. Epub 2012 Oct 3.

Responsible Party: Wafaie Fawzi, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT00197730     History of Changes
Other Study ID Numbers: HD43688
First Submitted: September 12, 2005
First Posted: September 20, 2005
Last Update Posted: August 21, 2009
Last Verified: August 2009

Keywords provided by Harvard School of Public Health:
Birth Outcomes
Nutrition
HIV
AIDS
Vitamins
Multivitamins
Maternal and child health outcomes
Tanzania
Africa

Additional relevant MeSH terms:
HIV Infections
Pregnancy Complications
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Vitamins
Folic Acid
Vitamin B Complex
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hematinics


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