Trial of Vitamins in HIV Progression and Transmission

NCT00197743 | Completed Phase 3 DMC

• 1 other identifier: HD32257
• Study Type: interventional
• Target: 1,085
• Locations: 1 country
• Sites: 1

Brief Summary

This study tested the hypothesis that multivitamin supplementation given to HIV+ pregnant women in Tanzania would slow disease progression and enhance their overall health.

Conditions

HIV Infections; Disease Transmission, Vertical

Keywords

HIV; Multivitamins; Pregnancy outcomes; Tanzania; Women

Outcome Measures

Primary Outcomes (1)

• To examine the effect of multivitamin and/or Vitamin A supplements on the risk of perinatal transmission of HIV and rate of HIV disease progression

  until the end of follow-up in August, 2003

Secondary Outcomes (1)

• To examine the effect of multivitamin and/or Vitamin A supplements on child and maternal morbidity, child growth and child mortality

  until the end of follow-up in August 2003

Study Arms (4)

Vitamin A

ACTIVE COMPARATOR

Vitamin A + Beta Carotene

Dietary Supplement: Vitamin A + Beta Carotene

Multivitamins

ACTIVE COMPARATOR

Vitamins B, C, and E

Dietary Supplement: Multivitamins

Vitamin A + Multivitamins

ACTIVE COMPARATOR

Vitamin A + Beta Carotene, Vitamins B, C, and E

Dietary Supplement: Vitamin A + Beta Carotene; Dietary Supplement: Multivitamins

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Vitamin A + Beta Carotene DIETARY_SUPPLEMENT

one daily oral dose of 30 mg beta-carotene + 5000 IU preformed vitamin A

Vitamin A; Vitamin A + Multivitamins

Multivitamins DIETARY_SUPPLEMENT

one daily oral dose of 20 mg thiamine (vitamin B-1), 20 mg riboflavin (vitamin B-2), 25 mg vitamin B-6, 100 mg niacin, 50 ug cobalamin (vitamin B-12), 500 mg vitamin C, 30 mg vitamin E, and 0.8 mg folic acid

Multivitamins; Vitamin A + Multivitamins

Placebo OTHER

Placebo pill

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-infected women presenting to antenatal care between 12 and 27 weeks of gestation:

Sponsors & Collaborators

• Harvard School of Public Health (HSPH): lead
• Muhimbili University of Health and Allied Sciences: collaborator

Study Sites (1)

Harvard School of Public Health

Boston, Massachusetts, 02115, United States

Location

Related Publications (6)

• Fawzi WW, Msamanga GI, Spiegelman D, Wei R, Kapiga S, Villamor E, Mwakagile D, Mugusi F, Hertzmark E, Essex M, Hunter DJ. A randomized trial of multivitamin supplements and HIV disease progression and mortality. N Engl J Med. 2004 Jul 1;351(1):23-32. doi: 10.1056/NEJMoa040541.

  PMID: 15229304 RESULT

• Fawzi WW, Msamanga GI, Hunter D, Renjifo B, Antelman G, Bang H, Manji K, Kapiga S, Mwakagile D, Essex M, Spiegelman D. Randomized trial of vitamin supplements in relation to transmission of HIV-1 through breastfeeding and early child mortality. AIDS. 2002 Sep 27;16(14):1935-44. doi: 10.1097/00002030-200209270-00011.

  PMID: 12351954 RESULT

• Fawzi WW, Msamanga G, Hunter D, Urassa E, Renjifo B, Mwakagile D, Hertzmark E, Coley J, Garland M, Kapiga S, Antelman G, Essex M, Spiegelman D. Randomized trial of vitamin supplements in relation to vertical transmission of HIV-1 in Tanzania. J Acquir Immune Defic Syndr. 2000 Mar 1;23(3):246-54. doi: 10.1097/00126334-200003010-00006.

  PMID: 10839660 RESULT

• Fawzi WW, Msamanga GI, Spiegelman D, Urassa EJ, McGrath N, Mwakagile D, Antelman G, Mbise R, Herrera G, Kapiga S, Willett W, Hunter DJ. Randomised trial of effects of vitamin supplements on pregnancy outcomes and T cell counts in HIV-1-infected women in Tanzania. Lancet. 1998 May 16;351(9114):1477-82. doi: 10.1016/s0140-6736(98)04197-x.

  PMID: 9605804 RESULT

• Khavari N, Jiang H, Manji K, Msamanga G, Spiegelman D, Fawzi W, Duggan C. Maternal multivitamin supplementation reduces the risk of diarrhoea among HIV-exposed children through age 5 years. Int Health. 2014 Dec;6(4):298-305. doi: 10.1093/inthealth/ihu061. Epub 2014 Aug 30.

  PMID: 25173342 DERIVED

• Natchu UC, Liu E, Duggan C, Msamanga G, Peterson K, Aboud S, Spiegelman D, Fawzi WW. Exclusive breastfeeding reduces risk of mortality in infants up to 6 mo of age born to HIV-positive Tanzanian women. Am J Clin Nutr. 2012 Nov;96(5):1071-8. doi: 10.3945/ajcn.111.024356. Epub 2012 Oct 10.

  PMID: 23053555 DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Vitamin A; beta Carotene; Geritol

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors

Study Officials

• Wafaie W Fawzi, MD,DrPh

  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: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: April 1, 1995
• Primary Completion: August 1, 2003
• Study Completion: August 1, 2003
• Last Updated: November 11, 2010

Record last verified: 2010-11

Locations

US (1)