Micronutrient deficiency and treatment adherence in a randomized controlled trial of micronutrient supplementation in ART-naïve persons with HIV

PLoS One. 2014 Jan 21;9(1):e85607. doi: 10.1371/journal.pone.0085607. eCollection 2014.

Abstract

Introduction: The MAINTAIN study is an on-going RCT comparing high-dose micronutrient and anti-oxidant supplementation versus recommended daily allowance (RDA) vitamins in slowing HIV immune deficiency progression in ART-naïve people with HIV infection.

Objective: We planned analysis of the first 127 participants to determine the baseline prevalence of serum micronutrient deficiencies and correlates, as well as tolerance and adherence to study interventions.

Methods: Participants receive eight capsules twice daily of 1) high-dose or 2) RDA supplements for two years and are followed-up quarterly for measures of immune deficiency progression, safety and tolerability. Regression analysis was used to identify correlates of micronutrient levels at baseline. Adherence was measured by residual pill count, self-report using the General Treatment Scale (GTS) and short-term recall HIV Adherence Treatment Scale (HATS).

Results: Prior micronutrient supplementation (within 30 days) was 27% at screening and 10% of study population, and was not correlated with baseline micronutrient levels. Low levels were frequent for carotene (24%<1 nmol/L), vitamin D (24%<40 nmol/L) and serum folate (20%<15 nmol/L). The proportion with B12 deficiency (<133 pmol/L) was 2.4%. Lower baseline levels of B12 correlated lower baseline CD4 count (r = 0.21, p = 0.02) with a 21 pmol/L reduction in B12 per 100 cells/µL CD4. Vitamin D levels were higher in men (p<0.001). After a median follow-up of 1.63 years, there were 19 (15%) early withdrawals from the study treatment. Mean treatment adherence using pill count was 88%. Subjective adherence by the GTS was 81% and was moderately but significantly correlated with pill count (r = 0.29, p<0.001). Adherence based on short-term recall (HATS) was >80% in 75% of participants.

Conclusion: Micronutrient levels in asymptomatic HIV+ persons are in keeping with population norms, but micronutrient deficiencies are frequent. Adherence levels are high, and will permit a valid evaluation of treatment effects.

Trial registration: ClinicalTrials.gov NCT00798772.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Anti-HIV Agents
  • CD4 Lymphocyte Count
  • Carotenoids / administration & dosage
  • Carotenoids / blood
  • Diet
  • Dietary Supplements*
  • Disease Progression
  • Female
  • Folic Acid / administration & dosage
  • Folic Acid / blood
  • HIV Infections / complications
  • HIV Infections / diet therapy*
  • HIV Infections / immunology
  • HIV Infections / virology
  • Humans
  • Male
  • Micronutrients / administration & dosage*
  • Middle Aged
  • Patient Compliance*
  • Recommended Dietary Allowances
  • Self Report
  • Vitamin B 12 / administration & dosage
  • Vitamin B 12 / blood
  • Vitamin B 12 Deficiency / complications
  • Vitamin B 12 Deficiency / diet therapy*
  • Vitamin B 12 Deficiency / immunology
  • Vitamin B 12 Deficiency / virology
  • Vitamin D / administration & dosage
  • Vitamin D / blood
  • Vitamin D Deficiency / complications
  • Vitamin D Deficiency / diet therapy*
  • Vitamin D Deficiency / immunology
  • Vitamin D Deficiency / virology

Substances

  • Anti-HIV Agents
  • Micronutrients
  • Vitamin D
  • Carotenoids
  • Folic Acid
  • Vitamin B 12

Associated data

  • ClinicalTrials.gov/NCT00798772