NCT00197730

Trial of Vitamins Among Children of HIV-infected Women

Completed Phase 3 Last updated 20 August 2009

What this trial tests

Phase 3 trial testing Multivitamins - vitamins B complex, C and E in HIV Infections in 2,387 participants. Completed in 1 May 2008.

Timeline

1 June 2004

Primary endpoint
1 May 2008

1 May 2008

Quick facts

Lead sponsor	Harvard School of Public Health (HSPH)
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	2,387
Start date	1 June 2004
Primary completion	1 May 2008
Estimated completion	1 May 2008
Sites	1 location across Tanzania

Drugs / interventions tested

• Multivitamins - vitamins B complex, C and E — full drug profile →
• Placebo

Conditions studied

• HIV Infections — all drugs for HIV Infections →
• Pregnancy Complications — all drugs for Pregnancy Complications →

Sponsor

Harvard School of Public Health (HSPH)

Who can join

Adults 6 Weeks to 24 Months, any sex, with HIV Infections or Pregnancy Complications. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• All-cause mortality and diarrheal morbidity
  Time frame: age 6 weeks to age 24 months

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Multiple micronutrient supplementation in Tanzanian infants born to HIV-infected mothers: a randomized, double-blind, placebo-controlled clinical trial.
   Duggan C, Manji KP, Kupka R, Bosch RJ, et al · · 2012 · cited 35× · PMID 23134887 · DOI 10.3945/ajcn.112.044263
2. Predictors of stunting, wasting and underweight among Tanzanian children born to HIV-infected women.
   McDonald CM, Kupka R, Manji KP, Okuma J, et al · · 2012 · cited 35× · PMID 23031850 · DOI 10.1038/ejcn.2012.136
3. High Burden of Morbidity and Mortality but Not Growth Failure in Infants Exposed to but Uninfected with Human Immunodeficiency Virus in Tanzania.
   Locks LM, Manji KP, Kupka R, Liu E, et al · · 2017 · cited 31× · PMID 27829511 · DOI 10.1016/j.jpeds.2016.09.040
4. Vitamin D status is associated with mortality, morbidity, and growth failure among a prospective cohort of HIV-infected and HIV-exposed Tanzanian infants.
   Sudfeld CR, Duggan C, Aboud S, Kupka R, et al · · 2015 · cited 28× · PMID 25527666 · DOI 10.3945/jn.114.201566
5. Multivitamin supplementation improves haematologic status in children born to HIV-positive women in Tanzania.
   Liu E, Duggan C, Manji KP, Kupka R, et al · · 2013 · cited 12× · PMID 23948440 · DOI 10.7448/ias.16.1.18022
6. Exclusive Breast-feeding Protects against Mother-to-Child Transmission of HIV-1 through 12 Months of Age in Tanzania.
   Manji KP, Duggan C, Liu E, Bosch R, et al · · 2016 · cited 11× · PMID 26999011 · DOI 10.1093/tropej/fmw012
7. Nutritional, Socioeconomic, and Delivery Characteristics Are Associated with Neurodevelopment in Tanzanian Children.
   Blakstad MM, Smith ER, Etheredge A, Locks LM, et al · · 2019 · cited 8× · PMID 30559023 · DOI 10.1016/j.jpeds.2018.10.066
8. Prevalence and risk factors for vitamin D deficiency among Tanzanian HIV-exposed uninfected infants.
   Rwebembera A, Sudfeld CR, Manji KP, Duggan C, et al · · 2013 · cited 8× · PMID 23619601 · DOI 10.1093/tropej/fmt028