HIV/AIDSPhase 3NCT01228578
Multi-vitamins, HAART and HIV/AIDS in Uganda
A Phase 3 study testing Multivitamin supplements B,C and E in people with HIV/AIDS, run by Harvard School of Public Health (HSPH) at 1 site in Uganda.
Trial summary
The investigators are conducting a double-blind, placebo controlled,randomized trial of multivitamin supplements(containing B-vitamins, C, and E) to determine their efficacy in slowing disease progression, indicated by increased CD4 count, weight gain, and improved quality of life, and decreased morbidity, mortality… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Multivitamin supplements B,C and E
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteUganda
- Study dates
- Apr 2010to Nov 2013
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men or women aged >=18 years old
- HIV-positive
- initiating anti-retroviral therapy at the time of randomization or have been on highly active anti-retroviral therapy (HAART) for no more than 6 months
- have no intention of migrating, or re-locating >= 20 km outside of the Infectious Disease Institute (IDI), or Kiswa Health Center within the next 18 months after enrollment
- agree to allow home visit(s) and subsequent follow-up contacts as part of the study
- provide written informed consent
Who cannot join
- pregnant Women
- individuals from whom we are unable to obtain written informed consent will be excluded from the study. For example, patients that are extremely ill and unable to consent will be excluded.
Trial locations and contacts
1 site in 1 country.
Uganda1 site
Makerere University School of Public Health / Infectious Disease Institute
Kampala
About this study
The investigators are conducting a double-blind, placebo controlled,randomized trial of multivitamin supplements(containing B-vitamins, C, and E) to determine their efficacy in slowing disease progression, indicated by increased CD4 count, weight gain, and improved quality of life, and decreased morbidity, mortality, and drug-related adverse events (i.e. peripheral neuropathy, anemia, and diarrhea).
The investigators hypothesize that daily multivitamin supplementation will: (1) improve immune reconstitution; (2) improve weight gain, and (3) improve quality of life.
Read the detailed description
Antiretroviral therapy, gradually becoming the standard of care in developing countries, confers enormous benefits and yet substantial morbidity remains in human immunodeficiency virus (HIV) positive populations. Multivitamin supplements have immune-enhancing effects, and supplements were found to improve immunologic status and reduce morbidity and mortality among HIV-positive Tanzanian women in pre-highly active anti-retroviral therapy (HAART) stages of disease. These supplements are thought to be required to restore adequate nutrient levels in the context of HIV infection.
This study will enroll 400 men and women in the Kampala district of Uganda, who are receiving or have recently initiated HAART. At baseline and monthly thereafter, research physicians and nurses at study clinics will assess each participant's clinical status and undertake study procedures. Each participant will be followed for 18 months, or until his/her death or loss to follow-up. Home visits will be conducted if participants miss their scheduled clinic appointments. We will perform nutritional assessments (anthropometry and dietary intake) at enrollment and several follow-up points, and laboratory measurements (CD4 cell counts and complete blood counts) every six months.
Importantly, all study participants will continue receiving the standard of care according to national guidelines for the entire study period. Multivitamins could be a low-cost, adjunct therapy for helping to alleviate disease burden and elevate quality of life in HIV-infected individuals on HAART. At the same time, their efficacy could help preserve limited drug regimens in developing settings by postponing the need for switches to second line regimens of HAART.
Our proposal represents a collaboration between the Harvard School of Public Health, Infectious Disease Institute and Makerere University School of Public Health in Kampala, Uganda.
- Conditions
- HIV/AIDS
- Being tested
- Multivitamin supplements B,C and E
- Keywords
- Multivitamins, HIV/AIDS, Immune reconstitution, Weight Gain, Quality of Life
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multivitamin supplements B,C and EDietary supplement
One daily recommended dietary allowance of multivitamins B,C and E or placebo taken daily for 18 months
| Study group | Role | What they receive |
|---|---|---|
| Multivitamins (B,C,E) | Experimental | Not described Receives: Dietary Supplement: Multivitamin supplements B,C and E |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Multivitamin supplements B,C and E |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Gain
Measured: 18 months
Immune Reconstitution
Immune Reconstitution is measured by change in CD4 cell count
Measured: 18 months
Improved Quality of Life
Measured: 18 months
Secondary outcomes (3)
New or recurrent disease progression event
Measured: 18 months
Reduce the probability of changing drug therapy (indicated by switching from first- to second-line therapy)
Measured: 18 months
Reduce HAART-associated adverse events (indicated by incident peripheral neuropathy, severe anemia, or diarrhea).
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2010 (estimated)
- Study startApr 2010
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- Makerere University, Infectious Disease Institute, Kampala, Uganda
- Responsible party
- Principal investigator, Wafaie Fawzi, Harvard School of Public Health (HSPH)
- Investigators
- Wafaie W Fawzi, MD,MPH,DrPH, Principal investigator, Harvard School of Public Health (HSPH)David Guwatudde, MPH, PhD, Principal investigator, Makerere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01228578
- Sponsor's protocol ID
- HD060333-01
- Status last verified
- May 2014
- First submitted
- 15 Oct 2010
- Last updated
- 22 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Guwatudde D, Wang M, Ezeamama AE, Bagenda D, Kyeyune R, Wamani H, Manabe YC, Fawzi WW. The effect of standard dose multivitamin supplementation on disease progression in HIV-infected adults initiating HAART: a randomized double blind placebo-controlled trial in Uganda. BMC Infect Dis. 2015 Aug 19;15:348. doi: 10.1186/s12879-015-1082-x.
PubMed 26285704Guwatudde D, Ezeamama AE, Bagenda D, Kyeyune R, Wabwire-Mangen F, Wamani H, Mugusi F, Spiegelman D, Wang M, Manabe YC, Fawzi WW. Multivitamin supplementation in HIV infected adults initiating antiretroviral therapy in Uganda: the protocol for a randomized double blinded placebo controlled efficacy trial. BMC Infect Dis. 2012 Nov 15;12:304. doi: 10.1186/1471-2334-12-304.
PubMed 23151221
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-vitamins, HAART and HIV/AIDS in Uganda
- ClinicalTrials.gov ID
- NCT01228578
- Acronym / sponsor ID
- HD060333-01
- Conditions
- HIV/AIDS
- Keywords
- Multivitamins, HIV/AIDS, Immune reconstitution, Weight Gain, Quality of Life
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- Makerere University, Infectious Disease Institute, Kampala, Uganda
- Study start
- Apr 2010
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 26 Oct 2010 (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.
The investigators are conducting a double-blind, placebo controlled,randomized trial of multivitamin supplements(containing B-vitamins, C, and E) to determine their efficacy in slowing disease progression, indicated by increased CD4 count, weight gain, and improved quality of life, and decreased morbidity, mortality, and drug-related adverse events (i.e. peripheral neuropathy, anemia, and diarrhea).
The investigators hypothesize that daily multivitamin supplementation will: (1) improve immune reconstitution; (2) improve weight gain, and (3) improve quality of life.
Detailed description
Antiretroviral therapy, gradually becoming the standard of care in developing countries, confers enormous benefits and yet substantial morbidity remains in human immunodeficiency virus (HIV) positive populations. Multivitamin supplements have immune-enhancing effects, and supplements were found to improve immunologic status and reduce morbidity and mortality among HIV-positive Tanzanian women in pre-highly active anti-retroviral therapy (HAART) stages of disease. These supplements are thought to be required to restore adequate nutrient levels in the context of HIV infection.
This study will enroll 400 men and women in the Kampala district of Uganda, who are receiving or have recently initiated HAART. At baseline and monthly thereafter, research physicians and nurses at study clinics will assess each participant's clinical status and undertake study procedures. Each participant will be followed for 18 months, or until his/her death or loss to follow-up. Home visits will be conducted if participants miss their scheduled clinic appointments. We will perform nutritional assessments (anthropometry and dietary intake) at enrollment and several follow-up points, and laboratory measurements (CD4 cell counts and complete blood counts) every six months.
Importantly, all study participants will continue receiving the standard of care according to national guidelines for the entire study period. Multivitamins could be a low-cost, adjunct therapy for helping to alleviate disease burden and elevate quality of life in HIV-infected individuals on HAART. At the same time, their efficacy could help preserve limited drug regimens in developing settings by postponing the need for switches to second line regimens of HAART.
Our proposal represents a collaboration between the Harvard School of Public Health, Infectious Disease Institute and Makerere University School of Public Health in Kampala, Uganda.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multivitamins (B,C,E) | Experimental | Dietary Supplement: Multivitamin supplements B,C and E |
| Placebo | Placebo comparator | Dietary Supplement: Multivitamin supplements B,C and E |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- men or women aged >=18 years old
- HIV-positive
- initiating anti-retroviral therapy at the time of randomization or have been on highly active anti-retroviral therapy (HAART) for no more than 6 months
- have no intention of migrating, or re-locating >= 20 km outside of the Infectious Disease Institute (IDI), or Kiswa Health Center within the next 18 months after enrollment
- agree to allow home visit(s) and subsequent follow-up contacts as part of the study
Key exclusion criteria (2 listed)
- pregnant Women
- individuals from whom we are unable to obtain written informed consent will be excluded from the study. For example, patients that are extremely ill and unable to consent will be excluded.
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 |
|---|---|---|
| Multivitamin supplements B,C and EOne daily recommended dietary allowance of multivitamins B,C and E or placebo taken daily for 18 months | Dietary supplement | Multivitamins (B,C,E), Placebo |
Primary outcome
Weight Gain
Time frame: 18 months
Immune Reconstitution
Time frame: 18 months
Immune Reconstitution is measured by change in CD4 cell count
Improved Quality of Life
Time frame: 18 months
3 secondary outcomes
New or recurrent disease progression event
Time frame: 18 months
Reduce the probability of changing drug therapy (indicated by switching from first- to second-line therapy)
Time frame: 18 months
Reduce HAART-associated adverse events (indicated by incident peripheral neuropathy, severe anemia, or diarrhea).
Time frame: 18 months
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 22 May 2014.
- Derived from this study: PubMed 26285704Guwatudde D, Wang M, Ezeamama AE, Bagenda D, Kyeyune R, Wamani H, Manabe YC, Fawzi WW. The effect of standard dose multivitamin supplementation on disease progression in HIV-infected adults initiating HAART: a randomized double blind placebo-controlled trial in Uganda. BMC Infect Dis. 2015 Aug 19;15:348. doi: 10.1186/s12879-015-1082-x.
- Derived from this study: PubMed 23151221Guwatudde D, Ezeamama AE, Bagenda D, Kyeyune R, Wabwire-Mangen F, Wamani H, Mugusi F, Spiegelman D, Wang M, Manabe YC, Fawzi WW. Multivitamin supplementation in HIV infected adults initiating antiretroviral therapy in Uganda: the protocol for a randomized double blinded placebo controlled efficacy trial. BMC Infect Dis. 2012 Nov 15;12:304. doi: 10.1186/1471-2334-12-304.
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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,MPH,DrPH principal investigator
Harvard School of Public Health (HSPH)
David Guwatudde, MPH, PhD principal investigator
Makerere University
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 Multivitamin supplements B,C and E in people with HIV/AIDS, run by Harvard School of Public Health (HSPH) at 1 site in Uganda.
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 6 inclusion and 2 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 22 May 2014. 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 Uganda. 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?
Weight Gain (time frame: 18 months). The study lists 3 primary outcomes in all. 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 NCT01228578, which also lists 2 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 22 May 2014.