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Nutrients. 2019 Jan 10;11(1). pii: E133. doi: 10.3390/nu11010133.

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

Author information

1
Center for Infectious Medicine (CIM), Department of Medicine Huddinge, Karolinska Institutet, Alfred Nobels Allé 8 (ANA8), 141 52 Huddinge, Sweden. Senait.Ashenafi.Betemariam@ki.se.
2
Department of Internal Medicine, School of Medicine, College of Health Sciences, Tikur Anbessa University Hospital and Addis Ababa University, Addis Ababa, Ethiopia. wonamogne@yahoo.com.
3
Department of Internal Medicine, School of Medicine, College of Health Sciences, Tikur Anbessa University Hospital and Addis Ababa University, Addis Ababa, Ethiopia. endalekl@yahoo.com.
4
Center for Infectious Medicine (CIM), Department of Medicine Huddinge, Karolinska Institutet, Alfred Nobels Allé 8 (ANA8), 141 52 Huddinge, Sweden. nebiatye@yahoo.com.
5
Armauer Hansen Research Institute (AHRI), Addis Ababa, Ethiopia. nebiatye@yahoo.com.
6
Department of Internal Medicine, School of Medicine, College of Health Sciences, Tikur Anbessa University Hospital and Addis Ababa University, Addis Ababa, Ethiopia. amsalubekele2016@gmail.com.
7
Department of Radiology, School of Medicine, College of Health Sciences, Tikur Anbessa University Hospital and Addis Ababa University, Addis Ababa, Ethiopia. g_asefa@yahoo.com.
8
Department of Internal Medicine, School of Medicine, College of Health Sciences, Tikur Anbessa University Hospital and Addis Ababa University, Addis Ababa, Ethiopia. merget2004@yahoo.com.
9
Armauer Hansen Research Institute (AHRI), Addis Ababa, Ethiopia. aseffaa@gmail.com.
10
Department of Public Health, School of Medicine, College of Health Sciences, Tikur Anbessa University Hospital and Addis Ababa University, Addis Ababa, Ethiopia. alemayehuwy@yahoo.com.
11
Institute of Environmental Medicine (IMM), Karolinska Institutet, 171 77 Stockholm, Sweden. ulf.hammar@ki.se.
12
Clinical Microbiology, Department of Laboratory Medicine (Labmed), Karolinska Institutet, Alfred Nobels Allé 8 (ANA8), 141 52 Huddinge, Sweden. peter.bergman@ki.se.
13
Department of Internal Medicine, School of Medicine, College of Health Sciences, Tikur Anbessa University Hospital and Addis Ababa University, Addis Ababa, Ethiopia. getadera@yahoo.com.
14
Center for Infectious Medicine (CIM), Department of Medicine Huddinge, Karolinska Institutet, Alfred Nobels Allé 8 (ANA8), 141 52 Huddinge, Sweden. jan.p.andersson@sll.se.
15
Department of Medicine Huddinge, Division of Infectious Diseases, Karolinska University Hospital Huddinge, 141 86 Stockholm, Sweden. jan.p.andersson@sll.se.
16
Center for Infectious Medicine (CIM), Department of Medicine Huddinge, Karolinska Institutet, Alfred Nobels Allé 8 (ANA8), 141 52 Huddinge, Sweden. susanna.brighenti@ki.se.

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.

KEYWORDS:

HIV infection; clinical trial; immunity; nutrition; supplementation; vitamin D

PMID:
30634590
PMCID:
PMC6356462
DOI:
10.3390/nu11010133
[Indexed for MEDLINE]
Free PMC Article

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