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Open AccessArticle

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

1
Center for Infectious Medicine (CIM), Department of Medicine Huddinge, Karolinska Institutet, Alfred Nobels Allé 8 (ANA8), 141 52 Huddinge, Sweden
2
Department of Internal Medicine, School of Medicine, College of Health Sciences, Tikur Anbessa University Hospital and Addis Ababa University, Addis Ababa, Ethiopia
3
Armauer Hansen Research Institute (AHRI), Addis Ababa, Ethiopia
4
Department of Radiology, School of Medicine, College of Health Sciences, Tikur Anbessa University Hospital and Addis Ababa University, Addis Ababa, Ethiopia
5
Department of Public Health, School of Medicine, College of Health Sciences, Tikur Anbessa University Hospital and Addis Ababa University, Addis Ababa, Ethiopia
6
Institute of Environmental Medicine (IMM), Karolinska Institutet, 171 77 Stockholm, Sweden
7
Clinical Microbiology, Department of Laboratory Medicine (Labmed), Karolinska Institutet, Alfred Nobels Allé 8 (ANA8), 141 52 Huddinge, Sweden
8
Department of Medicine Huddinge, Division of Infectious Diseases, Karolinska University Hospital Huddinge, 141 86 Stockholm, Sweden
*
Author to whom correspondence should be addressed.
These authors contributed equally to this work.
Nutrients 2019, 11(1), 133; https://doi.org/10.3390/nu11010133
Received: 14 November 2018 / Revised: 26 December 2018 / Accepted: 4 January 2019 / Published: 10 January 2019
(This article belongs to the Special Issue Targeted Nutrition in Chronic Disease)
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PDF [1307 KB, uploaded 11 January 2019]
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Abstract

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-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)D3 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 vitD3 deficient at enrolment, but a gradual and significant improvement of vitD3 status was demonstrated in the vitD3 + 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 vitD3 + PBA for 16 weeks was well-tolerated and effectively improved vitD3 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. View Full-Text
Keywords: vitamin D; nutrition; supplementation; HIV infection; clinical trial; immunity vitamin D; nutrition; supplementation; HIV infection; clinical trial; immunity
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Ashenafi, S.; Amogne, W.; Kassa, E.; Gebreselassie, N.; Bekele, A.; Aseffa, G.; Getachew, M.; Aseffa, A.; Worku, A.; Hammar, U.; Bergman, P.; Aderaye, G.; Andersson, J.; Brighenti, S. Daily Nutritional Supplementation with Vitamin D3 and Phenylbutyrate to Treatment-Naïve HIV Patients Tested in a Randomized Placebo-Controlled Trial. Nutrients 2019, 11, 133.

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