Vitamin D3 Supplementation Increases Spine Bone Mineral Density in Adolescents and Young Adults With Human Immunodeficiency Virus Infection Being Treated With Tenofovir Disoproxil Fumarate: A Randomized, Placebo-Controlled Trial

Havens, Peter L.; Stephensen, Charles B.; Loan, Marta D. Van; Schuster, Gertrud U.; Woodhouse, Leslie R.; Flynn, Patricia M.; Gordon, Catherine M.; Pan, Cynthia G.; Rutledge, Brandy; Harris, D.R.; Price, Georgine; Baker, Alyne; Meyer, William A.; Wilson, Craig M.; Hazra, Rohan; Kapogiannis, Bill G.; Mulligan, Kathleen; Vellala, Kavya; Wheeler, Justin; Fielding, Roger A.; Freytag, Tammy; Domek, Joseph M.; Gertz, Erik; Emmanuel, Patricia; Straub, Diane M.; Enriquez-Bruce, Elizabeth; Belzer, Marvin; Tucker, Diane C.; D'Angelo, Larry J.; Trexler, Connie; Douglas, Steve; Tanney, Mary; Stroger, John H.; Martínez, M. Garrido; Henry-Reid, Lisa; Bojan, Kelly; Futterman, Donna; Campos, Maria Isabela Guimarães; Abdalian, Sue Ellen; Kozina, Leslie; Friedman, Larry S.; Maturo, Donna; Guar, Aditya; Dillard, Mary; Paul, Mary; Head, Jane; Secord, Liz; Outlaw, Angulique Y.; Cromer, Charnell; Agwu, Allison L.; Sanders, Roger C.; Anderson, Thuy; Mayer, Ken; Dormitzer, Julian; Reirden, Dan; Chambers, Carrie Anne; Kovács, Andrea; Operskalski, Eva A.; Homans, James; Bearden, Allison; Sanchez, Susie; Puga, Ana Cristina; Eysallenne, Zulma; Acevedo, M.D. Piqueras; Rosario, Nicolas; Nieves, Lourdes Angeli; Wiznia, Andrew; Abadi, Jacob; Rosenberg, Michael; Dobroszycki, Joanna; Burey, Marlene

doi:10.1093/cid/cix753

Cited by 37 publications

(35 citation statements)

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“…Low dietary vitamin D intake among participants as compared to the Institute of Medicine (IOM) recommended daily allowance (RDA) was ubiquitous across studies. Similarly, dietary calcium intake was well below the RDA in the four studies to report this [ 56 , 57 , 64 , 72 ].…”

Section: Resultsmentioning

confidence: 96%

“…study which used D 2 (ergocalciferol) for supplementation [ 54 ]. Four studies supplemented calcium in conjunction with vitamin D [ 55 , 56 , 57 , 58 ] whereas three studies utilised a multiple-micronutrient supplement which did not contain calcium [ 59 , 60 , 61 ]. There was considerable dosing heterogeneity in regimens, ranging from 200–7,000 IU/day.…”

Section: Resultsmentioning

confidence: 99%

“…To achieve a measurement >75 nmol/L, higher supplementation doses (>1,000 IU) than currently recommended were required; though it should be noted that other guidelines such as the Special Advisory Committee on Nutrition (SACN) [ 40 ], IOM [ 74 ], and European Food Safety Agency [ 75 ] guidlines are to achieve population mean levels above the threshold not intended for clinical purposes. Higher mean and trough serum 25OHD values were almost always achieved after supplementation [ 54 , 55 , 57 , 64 , 66 , 70 – 73 , 76 , 77 ]. Higher mean monthly 25OHD values were seen with higher doses of cholecalciferol [ 55 ].…”

Section: Resultsmentioning

confidence: 99%

“…Maximal physiologic PTH suppression, however, was inconsistently observed after cholecalciferol supplementation. Whilst four studies demonstrated decreased serum PTH [ 54 , 57 , 67 , 72 ], three did not, despite similar cholecalciferol dosing [ 64 , 73 , 77 ]. Decreased PTH appeared to be in part dependent on participants’ exposure to tenofovir (TDF).…”

Section: Resultsmentioning

confidence: 99%

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The impact of vitamin D supplementation on musculoskeletal health outcomes in children, adolescents, and young adults living with HIV: A systematic review

et al. 2018

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ObjectiveHIV-positive children, adolescents, and young adults are at increased risk poor musculoskeletal outcomes. Increased incidence of vitamin D deficiency in youth living with HIV may further adversely affect musculoskeletal health. We investigated the impact of vitamin D supplementation on a range of musculoskeletal outcomes among individuals aged 0–25 years living with HIV.MethodsA systematic review was conducted using databases: PubMed/Medline, CINAHL, Web of Knowledge, and EMBASE. Interventional randomised control trials, quasi-experimental trials, and previous systematic reviews/meta-analyses were included. Outcomes included: BMD, BMC, fracture incidence, muscle strength, linear growth (height-for-age Z-score [HAZ]), and biochemical/endocrine biomarkers including bone turnover markers.ResultsOf 497 records, 20 studies met inclusion criteria. Thirteen studies were conducted in North America, one in Asia, two in Europe, and four in Sub-Saharan Africa. High-dose vitamin D supplementation regimens (1,000–7,000 IU/day) were successful in achieving serum 25-hydroxyvitamin-D (25OHD) concentrations above study-defined thresholds. No improvements were observed in BMD, BMC, or in muscle power, force and strength; however, improvements in neuromuscular motor skills were demonstrated. HAZ was unaffected by low-dose (200–400 IU/day) supplementation. A single study found positive effects on HAZ with high-dose supplementation (7,000 vs 4,000IU/day).ConclusionsMeasured bone outcomes were unaffected by high-dose vitamin D supplementation, even when target 25OHD measurements were achieved. This may be due to: insufficient sample size, follow-up, intermittent dosing, non-standardised definitions of vitamin D deficiency, or heterogeneity of enrolment criteria pertaining to baseline vitamin D concentration. High-dose vitamin D may improve HAZ and neuromuscular motor skills. Adequately powered trials are needed in settings where HIV burden is greatest.PROSPERO Number: CRD42016042938.

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Section: Resultsmentioning

confidence: 96%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

See 2 more Smart Citations

The impact of vitamin D supplementation on musculoskeletal health outcomes in children, adolescents, and young adults living with HIV: A systematic review

et al. 2018

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“…According to the latest version of the European AIDS Clinical Society Guidelines, vitamin D screening in patients receiving ARTs associated with low vitamin D levels is recommended (110). Recent studies in participants receiving EFV or TDF-cART showed that a dosage supplement of 50,000-60,000 IU per month was enough to reach the goal of 25(OH)D ≥30 ng/mL after 6 months (111,112).…”

Section: Antiretroviral Therapymentioning

confidence: 99%

DIAGNOSIS OF ENDOCRINE DISEASE: Drug-induced endocrinopathies and diabetes: a combo-endocrinology overview

Diamanti-Kandarakis

Duntas

Kanakis

et al. 2019

European Journal of Endocrinology

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In the currently overwhelming era of polypharmacy, the balance of the dynamic and delicate endocrine system can easily be disturbed by interfering pharmaceutical agents like medications. Drugs can cause endocrine abnormalities via different mechanisms, including direct alteration of hormone production, changes in the regulation of the feedback axis, on hormonal transport, binding and signaling, as well as similar changes to counter-regulatory hormone systems. Furthermore, drugs can interfere with the hormonal assays, leading to erroneous laboratory results that disorientate clinicians from the right diagnosis. The purpose of this review is to cover a contemporary topic, the drug-induced endocrinopathies, which was presented in the monothematic annual Combo Endo Course 2018. This challenging part of endocrinology is constantly expanding particularly during the last decade, with the new oncological therapeutic agents, targeting novel molecular pathways in the process of malignancies. In this new context of drug-induced endocrine disease, clinicians should be aware that drugs can cause endocrine abnormalities via different mechanisms and mimic a variety of clinical scenarios. Therefore, it is extremely important for clinicians not only to promptly recognize drug-induced hormonal and metabolic abnormalities, but also to address the therapeutic issues for timely intervention.

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Effects of vitamin D and calcium supplementation on bone mineral density among Thai youth using daily HIV pre‐exposure prophylaxis

Pornpaisalsakul

Songtaweesin

Tepmongkol

et al. 2020

J. Intern. AIDS Soc.

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Introduction: Tenofovir disoproxil fumarate with emtricitabine (TDF/FTC) is used for HIV pre-exposure prophylaxis (PrEP). TDF may affect bone mineral density (BMD), particularly in youth who are at a stage of peak bone mass accrual. The objective of this study was to evaluate the effect of vitamin D and calcium supplementation on BMD among Thai youth receiving daily oral PrEP. Methods: This open-label randomized trial was conducted in male youth aged between 15 and 24 years. Participants were randomized to Arm A who received once-daily TDF/FTC plus vitamin D3 and calcium supplementation with meals twice daily (400 units of vitamin D3 and 1200 mg of elemental calcium/day) or Arm B who received once-daily TDF/FTC only. PrEP users were defined as taking at least two tablets/week (tenofovir-diphosphate level of >350 fmol/punch). Adherence to vitamin D/calcium supplementation was defined as self-reported adherence of >50%. Lumbar spine (L2-L4) BMD (LSBMD) was evaluated by dual-energy X-ray absorptiometry scan zero and six months after PrEP initiation. Results: From March 2019 to March 2020, 100 youth were enrolled. Baseline characteristics between the two arms were similar. Median (IQR) age was 18 (17 to 20) years. At entry, median (IQR) LSBMD z-score was −0.8 (−1.5 to −0.3), 17% had low LSBMD (Z-score < −2). The median amount of calcium intake from nutritional three-day recall was 167 (IQR 94 to 272) mg/day, 39% of participants had vitamin D deficiency, defined as 25(OH)D levels <20 IU/mL. At six months, 79 participants were evaluated. Of these, 42 (52%) were PrEP takers and 25 of 38 (66%) of arm A participants had good adherence to vitamin D/calcium supplementation. Significantly higher proportions of youth in arm A compared to arm B had >3% increase in LSBMD at month 6 compared to baseline (67.6% vs. 42.9% respectively; p = 0.03). There were significantly higher increases in LSBMD among youth with vitamin D deficiency who were supplemented; arm A + 0.05 (0 to 0.05) compared to arm B + 0.03 (−0.1 to 0.03), p = 0.04. Conclusions: Increases in LSBMD over six months among youth using PrEP who received vitamin D/calcium supplementation was greater than those not supplemented. Long-term follow-up should be considered to explore long-term outcomes. Keywords: HIV pre-exposure prophylaxis; young men who have sex with men; young transgender women; bone mineral density; vitamin D; calcium Additional information may be found under the Supporting Information tab for this article.

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Vitamin D3 Supplementation Increases Spine Bone Mineral Density in Adolescents and Young Adults With Human Immunodeficiency Virus Infection Being Treated With Tenofovir Disoproxil Fumarate: A Randomized, Placebo-Controlled Trial

Abstract: NCT01751646.

Cited by 37 publications

References 36 publications

The impact of vitamin D supplementation on musculoskeletal health outcomes in children, adolescents, and young adults living with HIV: A systematic review

The impact of vitamin D supplementation on musculoskeletal health outcomes in children, adolescents, and young adults living with HIV: A systematic review

DIAGNOSIS OF ENDOCRINE DISEASE: Drug-induced endocrinopathies and diabetes: a combo-endocrinology overview

Effects of vitamin D and calcium supplementation on bone mineral density among Thai youth using daily HIV pre‐exposure prophylaxis

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