Micronutrient deficiency and treatment adherence in a randomized controlled trial of micronutrient supplementation in ART-naïve persons with HIV.
<h4>Introduction</h4>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.<h4>Objective</h4&g...
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oai:doaj.org-article:c149802bb02d460aaddb68287dc9d11a2021-11-18T08:37:00ZMicronutrient deficiency and treatment adherence in a randomized controlled trial of micronutrient supplementation in ART-naïve persons with HIV.1932-620310.1371/journal.pone.0085607https://doaj.org/article/c149802bb02d460aaddb68287dc9d11a2014-01-01T00:00:00Zhttps://www.ncbi.nlm.nih.gov/pmc/articles/pmid/24465617/pdf/?tool=EBIhttps://doaj.org/toc/1932-6203<h4>Introduction</h4>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.<h4>Objective</h4>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.<h4>Methods</h4>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).<h4>Results</h4>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.<h4>Conclusion</h4>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.<h4>Trial registration</h4>ClinicalTrials.gov NCT00798772.Louise BalfourJohanna N SpaansDean FergussonHarold HuffEdward J MillsCharles J la PorteSharon WalmsleyNeera SinghalRon RosenesNancy TremblayM John GillHugues LoembaBrian ConwayAnita RachlisEdward RalphMona LoutfyRanjeeta MallickRika MoorhouseD William CameronPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 9, Iss 1, p e85607 (2014) |
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Medicine R Science Q |
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Medicine R Science Q Louise Balfour Johanna N Spaans Dean Fergusson Harold Huff Edward J Mills Charles J la Porte Sharon Walmsley Neera Singhal Ron Rosenes Nancy Tremblay M John Gill Hugues Loemba Brian Conway Anita Rachlis Edward Ralph Mona Loutfy Ranjeeta Mallick Rika Moorhouse D William Cameron Micronutrient deficiency and treatment adherence in a randomized controlled trial of micronutrient supplementation in ART-naïve persons with HIV. |
| description |
<h4>Introduction</h4>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.<h4>Objective</h4>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.<h4>Methods</h4>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).<h4>Results</h4>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.<h4>Conclusion</h4>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.<h4>Trial registration</h4>ClinicalTrials.gov NCT00798772. |
| format |
article |
| author |
Louise Balfour Johanna N Spaans Dean Fergusson Harold Huff Edward J Mills Charles J la Porte Sharon Walmsley Neera Singhal Ron Rosenes Nancy Tremblay M John Gill Hugues Loemba Brian Conway Anita Rachlis Edward Ralph Mona Loutfy Ranjeeta Mallick Rika Moorhouse D William Cameron |
| author_facet |
Louise Balfour Johanna N Spaans Dean Fergusson Harold Huff Edward J Mills Charles J la Porte Sharon Walmsley Neera Singhal Ron Rosenes Nancy Tremblay M John Gill Hugues Loemba Brian Conway Anita Rachlis Edward Ralph Mona Loutfy Ranjeeta Mallick Rika Moorhouse D William Cameron |
| author_sort |
Louise Balfour |
| title |
Micronutrient deficiency and treatment adherence in a randomized controlled trial of micronutrient supplementation in ART-naïve persons with HIV. |
| title_short |
Micronutrient deficiency and treatment adherence in a randomized controlled trial of micronutrient supplementation in ART-naïve persons with HIV. |
| title_full |
Micronutrient deficiency and treatment adherence in a randomized controlled trial of micronutrient supplementation in ART-naïve persons with HIV. |
| title_fullStr |
Micronutrient deficiency and treatment adherence in a randomized controlled trial of micronutrient supplementation in ART-naïve persons with HIV. |
| title_full_unstemmed |
Micronutrient deficiency and treatment adherence in a randomized controlled trial of micronutrient supplementation in ART-naïve persons with HIV. |
| title_sort |
micronutrient deficiency and treatment adherence in a randomized controlled trial of micronutrient supplementation in art-naïve persons with hiv. |
| publisher |
Public Library of Science (PLoS) |
| publishDate |
2014 |
| url |
https://doaj.org/article/c149802bb02d460aaddb68287dc9d11a |
| work_keys_str_mv |
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