Micronutrient Deficiency and Treatment Adherence in a Randomized Controlled Trial of Micronutrient Supplementation in ART-Naïve Persons with HIV

Abstract

IntroductionThe 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.ObjectiveWe 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.MethodsParticipants 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).ResultsPrior 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.ConclusionMicronutrient 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 RegistrationClinicalTrials.gov NCT00798772

Oxidative Stress Predicts All-Cause Mortality in HIV-Infected Patients

“…Alternative measures to ART, including supplementation with micronutrients containing antioxidants, have been explored in the HIV population, with benefits shown in morbi-mortality in African pregnant women and children [ 37 ]. A large randomized controlled clinical trial is currently being conducted comparing high-dose micronutrient and anti-oxidant supplementation versus recommended daily allowance vitamins to slow HIV immune deficiency progression in ART-naïve people with HIV infection [ 38 ].…”

Food insecurity among students living with HIV: Strengthening safety nets at the Nelson Mandela Metropolitan University, South Africa

“…Micronutrient deficiencies in HIV-infected persons are common (Balfour, Spaans, Fergusson, Huff, Mills, la Porte, et al 2014 ). At the NMMU all HIV-infected students not eligible to receive ART are given monthly vitamin and mineral supplements to support the immune system.…”

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“…18,20 Regulation of metallothionein by zinc The most important factor in the modulation of MT is the amount of zinc intake. 21 Zinc deficiency is associated with poor wound healing, growth retardation, hair loss and weak immune function. 22 When zinc levels fall, skin rash, abdominal pain, loss of appetite, diarrhea and impaired taste and smell could occur.…”

“…Zinc supplementation however, can restore MT levels. 21,22 A cautious use of zinc supplement is advised because if zinc is administered for too long, it can cause depigmentation of hair and skin. In addition, excess zinc can result to copper deficiency.…”