NCT01228578

Brief 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, 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2010

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2010

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 26, 2010

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

May 22, 2014

Status Verified

May 1, 2014

Enrollment Period

3.6 years

First QC Date

October 15, 2010

Last Update Submit

May 20, 2014

Conditions

HIV/AIDS

Keywords

MultivitaminsHIV/AIDSImmune reconstitutionWeight GainQuality of Life

Outcome Measures

Primary Outcomes (3)

  • Weight Gain

    18 months

  • Immune Reconstitution

    Immune Reconstitution is measured by change in CD4 cell count

    18 months

  • Improved Quality of Life

    18 months

Secondary Outcomes (3)

  • New or recurrent disease progression event

    18 months

  • Reduce the probability of changing drug therapy (indicated by switching from first- to second-line therapy)

    18 months

  • Reduce HAART-associated adverse events (indicated by incident peripheral neuropathy, severe anemia, or diarrhea).

    18 months

Study Arms (2)

Multivitamins (B,C,E)

EXPERIMENTAL
Dietary Supplement: Multivitamin supplements B,C and E

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Multivitamin supplements B,C and E

Interventions

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

Multivitamins (B,C,E)Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Makerere University School of Public Health / Infectious Disease Institute

Kampala, Uganda

Location

Related Publications (2)

  • 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.

    PMID: 26285704DERIVED

  • Guwatudde 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.

    PMID: 23151221DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeWeight Gain

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Wafaie W Fawzi, MD,MPH,DrPH

    Harvard School of Public Health (HSPH)

    PRINCIPAL INVESTIGATOR

  • David Guwatudde, MPH, PhD

    Makerere University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 15, 2010

First Posted

October 26, 2010

Study Start

April 1, 2010

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

May 22, 2014

Record last verified: 2014-05

Locations

UG(1)