Micronutrients and Antioxidants in HIV Infection

NCT00798772 | Completed DMC

• 1 other identifier: CTN 238
• Study Type: interventional
• Target: 171
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Infection

Keywords

HIV infection; Micronutrients; Antioxidants

Outcome Measures

Primary Outcomes (1)

• 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

  Quarterly

Secondary Outcomes (10)

• Non-AIDS related adverse events

  Quarterly

• Tolerance of and adherence to study medication

  Quarterly

• Time from baseline to CD4+ cell count <350 cells/mm3 (confirmed by two measures at least one week apart)

  Quarterly

• Time from baseline to emergence of documented CDC-defined AIDS-defining illness

  Quarterly

• Time from baseline to start of ART

  Quarterly

Study Arms (2)

A: Broad spectrum micronutrients

EXPERIMENTAL

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

B: Identical appearing multivitamins

ACTIVE COMPARATOR

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

Interventions

Micronutrients and antioxidants DIETARY_SUPPLEMENT

8 capsules twice daily for two years

Also known as: K-PAX Ultra

A: Broad spectrum micronutrients

Multivitamins and minerals DIETARY_SUPPLEMENT

8 capsules twice daily for two years

Also known as: Centrum-like multivitamins and minerals

B: Identical appearing multivitamins

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• CIHR Canadian HIV Trials Network: collaborator
• Ontario HIV Treatment Network: collaborator

Study Sites (1)

The Ottawa Hospital, General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

Related Publications (4)

• Austin J, Singhal N, Voigt R, Smaill F, Gill MJ, Walmsley S, Salit I, Gilmour J, Schlech WF 3rd, Choudhri S, Rachlis A, Cohen J, Trottier S, Toma E, Phillips P, Ford PM, Woods R, Singer J, Zarowny DP, Cameron DW; CTN 091/CRIT Cartenoids Study Group. A community randomized controlled clinical trial of mixed carotenoids and micronutrient supplementation of patients with acquired immunodeficiency syndrome. Eur J Clin Nutr. 2006 Nov;60(11):1266-76. doi: 10.1038/sj.ejcn.1602447. Epub 2006 May 24.

  PMID: 16721396 BACKGROUND

• Kaiser JD, Campa AM, Ondercin JP, Leoung GS, Pless RF, Baum MK. Micronutrient supplementation increases CD4 count in HIV-infected individuals on highly active antiretroviral therapy: a prospective, double-blinded, placebo-controlled trial. J Acquir Immune Defic Syndr. 2006 Aug 15;42(5):523-8. doi: 10.1097/01.qai.0000230529.25083.42.

  PMID: 16868496 BACKGROUND

• Wobeser WL, McBane JE, Balfour L, Conway B, Gill MJ, Huff H, Kilby DLP, Fergusson DA, Mallick R, Mills EJ, Muldoon KA, Rachlis A, Ralph ED, Rosenes R, Singer J, Singhal N, Tan D, Tremblay N, Vo D, Walmsley SL, Cameron DW; MAINTAIN Study Group. A randomized control trial of high-dose micronutrient-antioxidant supplementation in healthy persons with untreated HIV infection. PLoS One. 2022 Jul 14;17(7):e0270590. doi: 10.1371/journal.pone.0270590. eCollection 2022.

  PMID: 35834528 DERIVED

• Balfour L, Spaans JN, Fergusson D, Huff H, Mills EJ, la Porte CJ, Walmsley S, Singhal N, Rosenes R, Tremblay N, Gill MJ, Loemba H, Conway B, Rachlis A, Ralph E, Loutfy M, Mallick R, Moorhouse R, William Cameron D. Micronutrient deficiency and treatment adherence in a randomized controlled trial of micronutrient supplementation in ART-naive persons with HIV. PLoS One. 2014 Jan 21;9(1):e85607. doi: 10.1371/journal.pone.0085607. eCollection 2014.

  PMID: 24465617 DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Micronutrients; Antioxidants; Geritol; Minerals

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Nutrients; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Biological Factors; Molecular Mechanisms of Pharmacological Action; Protective Agents; Specialty Uses of Chemicals; Inorganic Chemicals

Study Officials

• William Cameron, MD, FRCPC

  University of Ottawa at The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Treatment group (Group A): Will receive micronutrients and antioxidants. Control group (Group B): Will receive identical appearing RDA multivitamins and minerals

Study Record Dates

• First Submitted: November 25, 2008
• First Posted: November 26, 2008
• Study Start: January 1, 2009
• Primary Completion: May 1, 2014
• Study Completion: December 6, 2017
• Last Updated: April 17, 2018

Record last verified: 2018-04

Locations

CA (1)