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Daily Nutritional Supplementation with Vitamin D? and Phenylbutyrate to Treatment-Naive HIV Patients Tested in a Randomized Placebo-Controlled Trial.


ABSTRACT: Poor nutritional status is common among human immunodeficiency virus (HIV)-infected patients including vitamin D (vitD?) deficiency. We conducted a double-blinded, randomized, and placebo-controlled trial in Addis Ababa, Ethiopia, to investigate if daily nutritional supplementation with vitD? (5000 IU) and phenylbutyrate (PBA, 2 × 500 mg) could mediate beneficial effects in treatment-naïve HIV patients. Primary endpoint: the change in plasma HIV-1 comparing week 0 to 16 using modified intention-to-treat (mITT, n = 197) and per-protocol (n = 173) analyses. Secondary endpoints: longitudinal HIV viral load, T cell counts, body mass index (BMI), middle-upper-arm circumference (MUAC), and 25(OH)D? levels in plasma. Baseline characteristics were detectable viral loads (median 7897 copies/mL), low CD4? (median 410 cells/µL), and elevated CD8? (median 930 cells/µL) T cell counts. Most subjects were vitD? deficient at enrolment, but a gradual and significant improvement of vitD? status was demonstrated in the vitD? + PBA group compared with placebo (p < 0.0001) from week 0 to 16 (median 37.5 versus 115.5 nmol/L). No significant changes in HIV viral load, CD4? or CD8? T cell counts, BMI or MUAC could be detected. Clinical adverse events were similar in both groups. Daily vitD? + PBA for 16 weeks was well-tolerated and effectively improved vitD? status but did not reduce viral load, restore peripheral T cell counts or improve BMI or MUAC in HIV patients with slow progressive disease. Clinicaltrials.gov NCT01702974.

SUBMITTER: Ashenafi S 

PROVIDER: S-EPMC6356462 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Daily Nutritional Supplementation with Vitamin D₃ and Phenylbutyrate to Treatment-Naïve HIV Patients Tested in a Randomized Placebo-Controlled Trial.

Ashenafi Senait S   Amogne Wondwossen W   Kassa Endale E   Gebreselassie Nebiat N   Bekele Amsalu A   Aseffa Getachew G   Getachew Meron M   Aseffa Abraham A   Worku Alemayehu A   Hammar Ulf U   Bergman Peter P   Aderaye Getachew G   Andersson Jan J   Brighenti Susanna S  

Nutrients 20190110 1


Poor nutritional status is common among human immunodeficiency virus (HIV)-infected patients including vitamin D (vitD₃) deficiency. We conducted a double-blinded, randomized, and placebo-controlled trial in Addis Ababa, Ethiopia, to investigate if daily nutritional supplementation with vitD₃ (5000 IU) and phenylbutyrate (PBA, 2 × 500 mg) could mediate beneficial effects in treatment-naïve HIV patients. Primary endpoint: the change in plasma HIV-1 comparing week 0 to 16 using modified intention-  ...[more]

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