Comprehensive Safety Monitoring of 12‐Month Daily 7000‐IU Vitamin D<sub>3</sub> Supplementation in Human Immunodeficiency Virus–Infected Children and Young Adults

Schall, Joan I.; Hediger, Mary L.; Zemel, Babette S.; Rutstein, Richard M.; Stallings, Virginia A.

doi:10.1177/0148607115593790

Cited by 13 publications

(11 citation statements)

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“…Generally, a healthy person should consume between 400 and 600 IU (International Units) of VitD daily to maintain sufficiency. However, currently, the Institute of Medicine recommends a standard dose of 600 IU to maintain the requirements of 97.5% of the population, with 4000 IU as the maximum daily dose (51). The North American Endocrine Society recommends three times the standard dose for cART-adhering individuals living with HIV (6).…”

Section: Vitamin D Supplementation In Hiv-1 Infected Individualsmentioning

confidence: 99%

“…However, nine trials exceeded the maximum limits without adverse effects or associated toxicity (Table 1). Supplementation represents a risk when an individual has calcidiol (25 (OH) D) levels higher than 100 ng/mL or when serum calcium levels exceed 2.70 mmol/L (51). Usually, in these instances, the skeletal system, cell membrane permeability, and nerve impulses are affected, leading to muscle weakness or spasms, constant fatigue, kidney conditions, as well as digestive symptoms such as nausea and vomiting.…”

Section: Vitamin D Supplementation In Hiv-1 Infected Individualsmentioning

confidence: 99%

“…Although most of the doses increased VitD levels, sufficiency was challenging to achieve due to the severe deficiency suffered by the HIV-1 infected population. The use of 7000 IU daily was the most effective dose (51, 56, 60, 63, 66, 78), and restored sufficiency [defined as calcidiol serum levels >30 ng/mL (4)] in 80% of treated individuals with higher levels seen following 12 months of treatment (61). Only 2 of the 215 individuals treated with this regimen had calcidiol levels >90 ng/mL and hypercalcemia (66).…”

Section: Vitamin D Supplementation In Hiv-1 Infected Individualsmentioning

confidence: 99%

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The Potential Protective Role of Vitamin D Supplementation on HIV-1 Infection

2019

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HIV infection remains a global and public health issue with the incidence increasing in some countries. Despite the fact that combination antiretroviral therapy (cART) has decreased mortality and increased the life expectancy of HIV-infected individuals, non-AIDS conditions, mainly those associated with a persistent inflammatory state, have emerged as important causes of morbidity, and mortality despite effective antiviral therapy. One of the most common comorbidities in HIV-1 patients is Vitamin D (VitD) insufficiency, as VitD is a hormone that, in addition to its physiological role in mineral metabolism, has pleiotropic effects on immune regulation. Several reports have shown that VitD levels decrease during HIV disease progression and correlate with decreased survival rates, highlighting the importance of VitD supplementation during infection. An extensive review of 29 clinical studies of VitD supplementation in HIV-infected patients showed that regardless of cART, when VitD levels were increased to normal ranges, there was a decrease in inflammation, markers associated with bone turnover, and the risk of secondary hyperparathyroidism while the anti-bacterial response was increased. Additionally, in 3 of 7 studies, VitD supplementation led to an increase in CD4+ T cell count, although its effect on viral load was inconclusive since most patients were on cART. Similarly, previous evidence from our laboratory has shown that VitD can reduce the infection of CD4+ T cells in vitro. The effect of VitD supplementation on other HIV-associated conditions, such as cardiovascular diseases, dyslipidemia or hypertension, warrants further exploration. Currently, the available evidence suggests that there is a potential role for VitD supplementation in people living with HIV-1, however, comprehensive studies are required to define an adequate supplementation protocol for these individuals.

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Section: Vitamin D Supplementation In Hiv-1 Infected Individualsmentioning

confidence: 99%

Section: Vitamin D Supplementation In Hiv-1 Infected Individualsmentioning

confidence: 99%

Section: Vitamin D Supplementation In Hiv-1 Infected Individualsmentioning

confidence: 99%

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The Potential Protective Role of Vitamin D Supplementation on HIV-1 Infection

2019

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“…Nurses in Zimbabwe are respected, educated and well-trained. Across SSA where trained nurses provide HIV care, there are opportunities to capacitate these nurses to manage mental health comorbidities, such as problematic alcohol use [21,47]. Evidence-based interventions, such as MI-CBT for AUD, can be effectively delivered by up-skilling existing staff [20].…”

Section: Discussionmentioning

confidence: 99%

Effectiveness of a psychological intervention delivered by general nurses for alcohol use disorders in people living with HIV in Zimbabwe: a cluster randomized controlled trial

Madhombiro

Kidd

Dube

et al. 2020

J. Intern. AIDS Soc.

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Introduction There have been very few randomized clinical trials of interventions for alcohol use disorders (AUD) in people living with HIV (PLWH) in African countries. This is despite the fact that alcohol use is one of the modifiable risk factors for poor virological control in PLWH on antiretroviral therapy. Methods Sixteen clinic clusters in Zimbabwe were selected through stratified randomization and randomized 1: 1 to Intervention and Control arms. Inclusion criteria for individual participants were being adult, living with HIV and a probable alcohol use disorder as defined by a score of 6 (women) or 7 (men) on the Alcohol Use Disorders Identification Test (AUDIT). In the Intervention clusters, participants received 8 to 10 sessions of Motivational Interviewing blended with brief Cognitive Behavioural Therapy (MI‐CBT). In the control clusters, participants received four Enhanced Usual Care (EUC) sessions based on the alcohol treatment module from the World Health Organisation mhGAP intervention guide. General Nurses from the clinics were trained to deliver both treatments. The primary outcome was a change in AUDIT score at six‐month post‐randomization. Viral load, functioning and quality of life were secondary outcomes. A random‐effects analysis‐of‐covariance model was used to account for the cluster design. Results Two hundred and thirty‐four participants (n = 108 intervention and n = 126 control) were enrolled across 16 clinics. Participants were recruited from November 2016 to November 2017 and followed through to May 2018. Their mean age was 43.3 years (SD = 9.1) and 78.6% (n = 184) were male. At six months, the mean AUDIT score fell by −6.15 (95% CI −6.32; −6.00) in the MI‐CBT arm, compared to a fall of − 3.09 95 % CI − 3.21; −2.93) in the EUC arm (mean difference −3.09 (95% CI −4.53 to −1.23) ( p = 0.05). Viral load reduced and quality of life and functioning improved in both arms but the difference between arms was non‐significant. Conclusions Interventions for hazardous drinking and AUD comprising brief, multiple alcohol treatment sessions delivered by nurses in public HIV facilities in low‐income African countries can reduce problematic drinking among PLWH. Such interventions should be integrated into the primary care management of AUD and HIV and delivered by non‐specialist providers. Research is needed on cost‐effectiveness and implementation of such interventions, and on validation of cut‐points for alcohol use scales in low resource settings, in partnership with those with lived experience of HIV and AUD.

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“…This is in sharp contrast to another RCT that evaluated 7,000 IU/daily for 12 months in a similar population. In Schall, et al [60], the authors reported only 52% and 33% of subjects who reached a 25(OH)D concentration of ≥20 ng/mL and ≥32 ng/mL, respectively. However, only 77% of subjects were on cART at baseline, and the authors did not report HIV-1 RNA levels.…”

Section: Discussionmentioning

confidence: 99%

Effects of cholecalciferol supplementation on serum and urinary vitamin D metabolites and binding protein in HIV-infected youth

Eckard

Thierry-Palmer

Silvestrov

et al. 2017

The Journal of Steroid Biochemistry and Molecular Biology

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Vitamin D insufficiency is widespread in HIV-infected patients. HIV and/or antiretroviral therapy (ART), particularly efavirenz (EFV), may interfere with vitamin D metabolism. However, few data from randomized, controlled trials exist. Here, we investigate changes in vitamin D metabolites and binding protein (VDBP) after 6 months of supplementation in a randomized, active-control, double-blind trial investigating 2 different monthly cholecalciferol (vitamin D3) doses [60,000 (medium) or 120,000 (high) IU/month] vs. a control arm of 18,000 IU/month in 8–25 year old HIV-infected youth on ART with HIV-1 RNA <1000 copies/mL and baseline 25-hydroxycholecalciferol (25(OH)D3) ≤30 ng/mL. A matched healthy uninfected group was enrolled in a similar parallel study for comparison. Changes after 6 months were analyzed as intent-to-treat within/between groups [control group (low dose) vs. combined supplementation doses (medium+high)]. At 6 months, 55% vs. 82% of subjects in control and supplementation groups, respectively, reached 25(OH)D3 ≥30 ng/mL (P=0.01) with no difference between medium and high doses (both 82% ≥30 ng/mL). There were few differences for those on EFV vs. no-EFV, except serum VDBP decreased in EFV-treated subjects (both within- and between-groups P≤0.01). There were no significant differences between the HIV-infected vs. healthy uninfected groups. The major finding of the present study is that cholecalciferol supplementation (60,000 or 120,000 IU/month) effectively raises serum 25(OH)D3 in the majority of HIV-infected subjects, regardless of EFV use. Notably, response to supplementation was similar to that of uninfected subjects.

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Comprehensive Safety Monitoring of 12‐Month Daily 7000‐IU Vitamin D₃ Supplementation in Human Immunodeficiency Virus–Infected Children and Young Adults

Abstract: Safety of daily 7000-IU vitD3 supplementation in children and young adults with HIV was comprehensively monitored over 12 months. High-dose daily vitD3 supplementation was efficacious in improving vitamin D status, and there were no safety events.

Cited by 13 publications

References 12 publications

The Potential Protective Role of Vitamin D Supplementation on HIV-1 Infection

The Potential Protective Role of Vitamin D Supplementation on HIV-1 Infection

Effectiveness of a psychological intervention delivered by general nurses for alcohol use disorders in people living with HIV in Zimbabwe: a cluster randomized controlled trial

Effects of cholecalciferol supplementation on serum and urinary vitamin D metabolites and binding protein in HIV-infected youth

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Comprehensive Safety Monitoring of 12‐Month Daily 7000‐IU Vitamin D3 Supplementation in Human Immunodeficiency Virus–Infected Children and Young Adults

Abstract: Safety of daily 7000-IU vitD3 supplementation in children and young adults with HIV was comprehensively monitored over 12 months. High-dose daily vitD3 supplementation was efficacious in improving vitamin D status, and there were no safety events.

Cited by 13 publications

References 12 publications

The Potential Protective Role of Vitamin D Supplementation on HIV-1 Infection

The Potential Protective Role of Vitamin D Supplementation on HIV-1 Infection

Effectiveness of a psychological intervention delivered by general nurses for alcohol use disorders in people living with HIV in Zimbabwe: a cluster randomized controlled trial

Effects of cholecalciferol supplementation on serum and urinary vitamin D metabolites and binding protein in HIV-infected youth

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Comprehensive Safety Monitoring of 12‐Month Daily 7000‐IU Vitamin D₃ Supplementation in Human Immunodeficiency Virus–Infected Children and Young Adults