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Daily Nutritional S...
Daily Nutritional Supplementation with Vitamin D₃ and Phenylbutyrate to Treatment-Naïve HIV Patients Tested in a Randomized Placebo-Controlled Trial
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- Ashenafi, S (författare)
- Karolinska Institutet
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Amogne, W (författare)
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Kassa, E (författare)
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Gebreselassie, N (författare)
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Bekele, A (författare)
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Aseffa, G (författare)
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Getachew, M (författare)
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Aseffa, A (författare)
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Worku, A (författare)
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Hammar, U (författare)
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- Bergman, P (författare)
- Karolinska Institutet
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Aderaye, G (författare)
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Andersson, J (författare)
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- Brighenti, S (författare)
- Karolinska Institutet
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(creator_code:org_t)
- 2019-01-10
- 2019
- Engelska.
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Ingår i: Nutrients. - : MDPI AG. - 2072-6643. ; 11:1
- Relaterad länk:
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https://www.mdpi.com...
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http://kipublication...
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https://doi.org/10.3...
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Abstract
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- 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.
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Ashenafi, S
-
Amogne, W
-
Kassa, E
-
Gebreselassie, N
-
Bekele, A
-
Aseffa, G
-
visa fler...
-
Getachew, M
-
Aseffa, A
-
Worku, A
-
Hammar, U
-
Bergman, P
-
Aderaye, G
-
Andersson, J
-
Brighenti, S
-
visa färre...
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Nutrients
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Karolinska Institutet