Trial of Vitamins Among Children of HIV-infected Women

This study has been completed.
Sponsor:
Collaborator:
Muhimbili University of Health and Allied Sciences
Information provided by:
Harvard School of Public Health
ClinicalTrials.gov Identifier:
NCT00197730
First received: September 12, 2005
Last updated: August 20, 2009
Last verified: August 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   6 Weeks to 24 Months
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Harvard School of Public Health

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wafaie Fawzi, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT00197730     History of Changes
Other Study ID Numbers: HD43688
Study First Received: September 12, 2005
Last Updated: August 20, 2009
Health Authority: United States: Federal Government
Tanzania: Ministry of Health

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
Acquired Immunodeficiency Syndrome
Pregnancy Complications
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Vitamin B Complex
Folic Acid
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014