66555
document
High-dose vitamin D3 supplementation in children and young adults with HIV : a randomized , placebo-controlled trial . BACKGROUND Suboptimal vitamin D status is prevalent in HIV-infected patients and associated with increased risk of disease severity and morbidity . We aimed to determine 12-month safety and efficacy of daily 7000 IU vitamin D3 ( vitD3 ) versus placebo to sustain increased serum 25-hydroxyvitamin D ( 25 ( OH ) D ) and improve immune status in HIV-infected subjects . METHODS This was a double-blind trial of perinatally acquired HIV ( PHIV ) -infected subjects or behaviorally acquired HIV ( BHIV ) -infected subjects ( 5.0-24.9 years ) . Safety , 25 ( OH ) D-related parameters and immune status were assessed at baseline , 3 , 6 and 12 months . RESULTS Fifty-eight subjects enrolled ( 67 % male , 85 % African American and 64 % BHIV ) and 50 completed with no safety concerns . In unadjusted analyses , there were no differences between randomization groups at baseline ; at 3 , 6 and 12 months , 25 ( OH ) D was higher with supplementation than baseline and higher than with placebo ( P < 0.05 ) . In adjusted mixed models , in the supplementation group , the fixed effect of 25 ( OH ) D was higher ( P < 0.001 ) . Percentage of naive T-helper cells ( Th naive % ) were significantly ( P < 0.01 ) and T-helper cells ( CD4 % ) marginally ( P < 0.10 ) increased with supplementation in those taking highly active antiretroviral therapy ( HAART ) , and RNA viral load was reduced ( P ≤ 0.05 ) . In exploratory linear models , change in 25 ( OH ) D predicted RNA viral load at 3 and 12 months and CD4 % at 3 months ( P < 0.05 ) . CONCLUSIONS Daily 7000 IU vitD3 for 12 months was safe in HIV-infected subjects and effective in increasing 25 ( OH ) D. Supplementation improved some clinically important HIV immune markers in subjects on HAART . Adjunct therapy with high-dose , daily vitD3 for HIV-infected subjects and for those on/off HAART requires further investigation .
66556
Intervention_Pharmacological
vitamin D3 supplementation
66557
Intervention_Control
placebo-controlled trial
66558
Intervention_Pharmacological
7000 IU vitamin D3
66559
Intervention_Control
placebo
66560
Outcome_Physical
HIV :
66561
Outcome_Other
safety and efficacy
66562
Outcome_Physical
increased serum 25-hydroxyvitamin D ( 25 ( OH ) D ) and improve immune status
66563
Outcome_Other
Safety
66564
Outcome_Other
25 ( OH ) D-related parameters
66565
Outcome_Physical
immune status
66566
Outcome_Other
safety concerns .
66567
Outcome_Physical
25 ( OH ) D
66568
Outcome_Physical
Percentage of naive T-helper cells ( Th naive % )
66569
Outcome_Physical
T-helper cells ( CD4 % )
66570
Outcome_Physical
RNA viral load
66571
Outcome_Physical
in 25 ( OH ) D predicted RNA viral load
66572
Outcome_Physical
and CD4 %
66573
Outcome_Physical
increasing 25 ( OH )
66574
Outcome_Physical
some clinically important HIV immune markers
66575
Participant_Age
children and young adults
66576
Participant_Condition
HIV
66577
Participant_Condition
HIV-infected
66578
Participant_Condition
HIV-infected subjects
66579
Participant_Condition
perinatally acquired HIV ( PHIV ) -infected subjects
66580
Participant_Condition
behaviorally acquired HIV ( BHIV ) -infected subjects
66581
Participant_Age
5.0-24.9 years
66582
Participant_Sample-size
Fifty-eight subjects enrolled
66583
Participant_Sex
67 % male
66584
Participant_Sample-size
85 % African American
66585
Participant_Sample-size
64 %
66586
Participant_Sample-size
50 completed with no safety concerns