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AzTrials

HIV InfectionsPhase 3NCT00197730

Trial of Vitamins Among Children of HIV-infected Women

A Phase 3 study testing Multivitamins - vitamins B complex, C and E in people with HIV Infections and Pregnancy Complications, run by Harvard School of Public Health (HSPH) at 1 site in Tanzania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 6 weeks to 24 months
Conditions the study is for
HIV Infections, Pregnancy Complications
What is being tested?
Multivitamins - vitamins B complex, C and E
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,387 participants
Where
1 siteTanzania
Study dates
Jun 2004to May 2008
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 weeks to 24 months
  • All sexes
  • No healthy volunteers
  • Child

Inclusion Criteria: Singleton, live born infants born to HIV-infected women Exclusion Criteria: Infants with multiple congenital abnormalities

Trial locations and contacts

1 site in 1 country.

Tanzania1 site

  • Muhimbili University of Health and Allied Sciences

    Dar es Salaam

Other trials in Tanzania

About this study

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.

Read the 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.

Being tested
Multivitamins - vitamins B complex, C and E, Placebo
Keywords
Birth Outcomes, Nutrition, HIV, AIDS, Vitamins, Multivitamins, Maternal and child health outcomes, Tanzania, Africa
Medical subject headings
HIV Infections, Pregnancy Complications, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multivitamins - vitamins B complex, C and EDrug

    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

  • PlaceboDrug

    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

Study groups in NCT00197730
Study groupRoleWhat they receive
MultivitaminsExperimentalVitamin E, Vitamin C, and Vitamin B complex
Receives: Drug: Multivitamins - vitamins B complex, C and E
PlaceboPlacebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause mortality and diarrheal morbidity

    Measured: age 6 weeks to age 24 months

Secondary outcomes (1)

  1. Child growth faltering, lower respiratory infections, HIV breastfeeding transmission, and maternal HIV disease progression in relation to breastfeeding

    Measured: age 6 weeks to 24 months post partum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2005 (estimated)
  2. Study startJun 2004
  3. Primary completionMay 2008
  4. Study completionMay 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2,387 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00197730
Sponsor's protocol ID
HD43688
Status last verified
Aug 2009
First submitted
12 Sep 2005
Last updated
21 Aug 2009
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 32842043

  • 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.

    PubMed 30559023

  • 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.

    PubMed 28499715

  • 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.

    PubMed 27829511

  • 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.

    PubMed 27245295

  • Manji KP, Duggan C, Liu E, Bosch R, Kisenge R, Aboud S, Kupka R, Fawzi WW. Exclusive Breast-feeding Protects against Mother-to-Child Transmission of HIV-1 through 12 Months of Age in Tanzania. J Trop Pediatr. 2016 Aug;62(4):301-7. doi: 10.1093/tropej/fmw012. Epub 2016 Mar 15.

    PubMed 26999011

  • 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.

    PubMed 25527666

  • 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.

    PubMed 23720367

  • 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.

    PubMed 23514773

  • 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.

    PubMed 23134887

  • 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.

    PubMed 23031850

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Multivitamins - vitamins B complex, C and E in people with HIV Infections and Pregnancy Complications, run by Harvard School of Public Health (HSPH) at 1 site in Tanzania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause mortality and diarrheal morbidity (time frame: age 6 weeks to age 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00197730, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2009.

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