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Micronutrients and Antioxidants in HIV Infection (MAINTAIN)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
CIHR Canadian HIV Trials Network
Ontario HIV Treatment Network
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00798772
First received: November 25, 2008
Last updated: April 3, 2017
Last verified: April 2016
  Purpose
Infection with human immunodeficiency virus (HIV) causes decline in immunity or the ability to fight infection and progresses to acquired immunodeficiency disease (AIDS). Anti-HIV drug treatment has improved the prognosis of persons with HIV infection, but is expensive and potentially toxic. Low micronutrient levels occur in the blood even in early stages of HIV infection and increase risk of a poorer prognosis, but the role of micronutrient and antioxidant supplements in medical management of HIV/AIDS is not well defined. The proposed clinical trial aims to assess if supplementation of untreated HIV-infected adults with a micronutrient and antioxidant preparation can delay decline in immunity or disease progression or start of anti-HIV drug treatment compared with supplementation with standard multivitamins. If the findings are positive, the study has implications for health and health care savings.

Condition Intervention
HIV Infection Dietary Supplement: Micronutrients and antioxidants Dietary Supplement: Multivitamins and minerals

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Treatment group (Group A): Will receive micronutrients and antioxidants. Control group (Group B): Will receive identical appearing RDA multivitamins and minerals
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Control Clinical Trial Of Micronutrient & Antioxidant Supplementation in Persons With Untreated HIV Infection

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Time from baseline to CD4+ cell count <350 cells/mm3 (confirmed by two measures at least one week apart), or emergence of documented CDC-defined AIDS-defining illness, or start of ART [ Time Frame: Quarterly ]

Secondary Outcome Measures:
  • Non-AIDS related adverse events [ Time Frame: Quarterly ]
  • Tolerance of and adherence to study medication [ Time Frame: Quarterly ]
  • Time from baseline to CD4+ cell count <350 cells/mm3 (confirmed by two measures at least one week apart) [ Time Frame: Quarterly ]
  • Time from baseline to emergence of documented CDC-defined AIDS-defining illness [ Time Frame: Quarterly ]
  • Time from baseline to start of ART [ Time Frame: Quarterly ]
  • Serial quarterly lymphocyte measures (ALC, CD4+, CD8+, and CD3+ cell counts, CD4%, CD8%, CD4:CD8) [ Time Frame: Quarterly ]
  • Serial quarterly HIV RNA plasma viral load [ Time Frame: Quarterly ]
  • Serum chemistries: Glucose, BUN, creatinine, total protein, albumin, alkaline phosphatase, ALT, AST, total bilirubin, [ Time Frame: Quarterly ]
  • Serum micronutrient levels: carotene (quarterly), vitamin B12 (quarterly), folate (six monthly) and vitamin D (25-OHD six monthly) [ Time Frame: Quarterly or as specified ]
  • Quality of Life measures [ Time Frame: Quarterly ]

Estimated Enrollment: 218
Study Start Date: January 2009
Estimated Study Completion Date: December 2017
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A: Broad spectrum micronutrients

The experimental treatment medications (micronutrients and antioxidants) will be taken as one packet (8 capsules) twice a day with meals. Because of the presence of calcium, iron and zinc in the study medication, any other medication must be taken at least two hours before or after taking it. Participants may initiate the intervention at half dose (one packet of 8 capsules once a day) and increase to full dose after one week.

The intervention will last for two years.

Dietary Supplement: Micronutrients and antioxidants
8 capsules twice daily for two years
Other Name: K-PAX Ultra
Active Comparator: B: Identical appearing multivitamins

The active comparator/control medications (identical appearing RDA multivitamins and minerals) will be taken as one packet (8 capsules) twice a day with meals. Because of the presence of calcium, iron and zinc in the study medication, any other medication must be taken at least two hours before or after taking it. Participants may initiate the intervention at half dose (one packet of 8 capsules once a day) and increase to full dose after one week.

The intervention will last for two years.

Dietary Supplement: Multivitamins and minerals
8 capsules twice daily for two years
Other Name: Centrum-like multivitamins and minerals

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • be an asymptomatic HIV infected adult
  • at least 18 years of age
  • have CD4+ cells between 375 and 750 cells/mm3
  • have received no ART (excluding less than seven days and perinatal transmission prophylaxis)
  • if a woman of child bearing potential, have a negative pregnancy test within two weeks prior to randomization and agree to practice barrier method of birth control during the study
  • be willing and able to sign informed consent and to comply with the study protocol

Exclusion Criteria:

  • have HIV-2 infection alone
  • have known allergy or intolerance to any study medication ingredient
  • be pregnant
  • have active treatment for an acute opportunistic infection or malignancy
  • have ALT greater than 3 x normal range
  • have known cirrhosis of the liver
  • have serum creatinine less than 133 umol/L
  • abuse alcohol and recreational drugs
  • be taking micronutrient (except vitamin D*) or natural health product supplements within 30 days of randomization *Maximum 2000 IU daily (Health Canada Guidelines).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00798772

Locations
Canada, Ontario
The Ottawa Hospital, General Campus
Ottawa, Ontario, Canada, K1H 8L6
Sponsors and Collaborators
Ottawa Hospital Research Institute
CIHR Canadian HIV Trials Network
Ontario HIV Treatment Network
Investigators
Principal Investigator: William Cameron, MD, FRCPC University of Ottawa at The Ottawa Hospital
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00798772     History of Changes
Other Study ID Numbers: CTN 238
Study First Received: November 25, 2008
Last Updated: April 3, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Ottawa Hospital Research Institute:
HIV infection
Micronutrients
Antioxidants

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Antioxidants
Micronutrients
Trace Elements
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Growth Substances

ClinicalTrials.gov processed this record on August 22, 2017