HIV InfectionsPhase 3NCT00197743
Trial of Vitamins in HIV Progression and Transmission
A Phase 3 study testing Vitamin A + Beta Carotene and Multivitamins in people with HIV Infections and Disease Transmission, Vertical, run by Harvard School of Public Health (HSPH) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV Infections, Disease Transmission, Vertical
- What is being tested?
- Vitamin A + Beta Carotene and Multivitamins
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,085 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 1995to Aug 2003
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-infected women presenting to antenatal care between 12 and 27 weeks of gestation:
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Harvard School of Public Health
Boston, Massachusetts, 02115
About this study
This study tested the hypothesis that multivitamin supplementation given to HIV+ pregnant women in Tanzania would slow disease progression and enhance their overall health.
Read the detailed description
In this study, we sought to examine whether the administration of multivitamins excluding vitamin A, multivitamins including vitamin A, or vitamin A alone would reduce the risk of perinatal transmission of HIV and slow the rate of disease progression in a group of pregnant HIV infected women. We also examined the efficacy of the supplements on pregnancy outcomes, and risks of maternal and child morbidity and wasting.
- Conditions
- HIV Infections, Disease Transmission, Vertical
- Being tested
- Vitamin A + Beta Carotene, Multivitamins, Placebo
- Keywords
- HIV, Multivitamins, Pregnancy outcomes, Tanzania, Women
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin A + Beta CaroteneDietary supplement
one daily oral dose of 30 mg beta-carotene + 5000 IU preformed vitamin A
MultivitaminsDietary 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
PlaceboOther
Placebo pill
| Study group | Role | What they receive |
|---|---|---|
| Vitamin A | Active comparator | Vitamin A + Beta Carotene Receives: Dietary Supplement: Vitamin A + Beta Carotene |
| Multivitamins | Active comparator | Vitamins B, C, and E Receives: Dietary Supplement: Multivitamins |
| Vitamin A + Multivitamins | Active comparator | Vitamin A + Beta Carotene, Vitamins B, C, and E Receives: Dietary Supplement: Vitamin A + Beta Carotene; Dietary Supplement: Multivitamins |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: until the end of follow-up in August 2003
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startApr 1995
- Primary completionAug 2003
- Study completionAug 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 1,085 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- Muhimbili University of Health and Allied Sciences
- Investigators
- Wafaie W Fawzi, MD,DrPh, Principal investigator, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00197743
- Sponsor's protocol ID
- HD32257
- Status last verified
- Nov 2010
- First submitted
- 13 Sep 2005
- Last updated
- 11 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 15229304Fawzi 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.
PubMed 12351954Fawzi 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.
PubMed 10839660Fawzi 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.
PubMed 9605804Khavari 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.
PubMed 25173342Natchu 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.
PubMed 23053555
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Vitamins in HIV Progression and Transmission
- ClinicalTrials.gov ID
- NCT00197743
- Acronym / sponsor ID
- HD32257
- Conditions
- HIV Infections, Disease Transmission, Vertical
- Keywords
- HIV, Multivitamins, Pregnancy outcomes, Tanzania, Women
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,085 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- Muhimbili University of Health and Allied Sciences
- Study start
- Apr 1995
- Primary completion
- Aug 2003 (actual)
- Study completion
- Aug 2003 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study tested the hypothesis that multivitamin supplementation given to HIV+ pregnant women in Tanzania would slow disease progression and enhance their overall health.
Detailed description
In this study, we sought to examine whether the administration of multivitamins excluding vitamin A, multivitamins including vitamin A, or vitamin A alone would reduce the risk of perinatal transmission of HIV and slow the rate of disease progression in a group of pregnant HIV infected women. We also examined the efficacy of the supplements on pregnancy outcomes, and risks of maternal and child morbidity and wasting.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vitamin A | Active comparator | Dietary Supplement: Vitamin A + Beta CaroteneVitamin A + Beta Carotene |
| Multivitamins | Active comparator | Dietary Supplement: MultivitaminsVitamins B, C, and E |
| Vitamin A + Multivitamins | Active comparator | Dietary Supplement: Vitamin A + Beta Carotene, Dietary Supplement: MultivitaminsVitamin A + Beta Carotene, Vitamins B, C, and E |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- HIV-infected women presenting to antenatal care between 12 and 27 weeks of gestation:
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin A + Beta Caroteneone daily oral dose of 30 mg beta-carotene + 5000 IU preformed vitamin A | Dietary supplement | Vitamin A, Vitamin A + Multivitamins |
| Multivitaminsone 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 | Dietary supplement | Multivitamins, Vitamin A + Multivitamins |
| PlaceboPlacebo pill | Other | Placebo |
Primary outcome
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
Time frame: until the end of follow-up in August, 2003
1 secondary outcome
To examine the effect of multivitamin and/or Vitamin A supplements on child and maternal morbidity, child growth and child mortality
Time frame: until the end of follow-up in August 2003
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2010.
- Results publication: PubMed 15229304Fawzi 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.
- Results publication: PubMed 12351954Fawzi 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.
- Results publication: PubMed 10839660Fawzi 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.
- Results publication: PubMed 9605804Fawzi 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.
- Derived from this study: PubMed 25173342Khavari 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.
- Derived from this study: PubMed 23053555Natchu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wafaie W Fawzi, MD,DrPh principal investigator
Harvard School of Public Health (HSPH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin A + Beta Carotene and Multivitamins in people with HIV Infections and Disease Transmission, Vertical, run by Harvard School of Public Health (HSPH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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 11 Nov 2010. 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 United States. 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?
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 (time frame: until the end of follow-up in August, 2003). 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 NCT00197743, which also lists 6 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 11 Nov 2010.