Dietary Supplements

Impact of high-dose vitamin D and calcium carbonate supplementation on bone density in adolescents living with HIV: a randomised, placebo-controlled trial.

TL;DR

There was no difference in bone density between arms overall, but among those with vitamin D insufficiency the intervention improved bone density, suggesting high-dose vitamin D3 and calcium supplementation might promote bone accrual and mineralisation in adolescents living with perinatally acquired HIV.

Key Findings

High-dose weekly vitamin D3 and daily calcium carbonate supplementation for 48 weeks did not significantly improve total body less-head bone mineral density Z score overall in adolescents with perinatally acquired HIV.

  • 842 participants enrolled (median age 15 years [IQR 13-17], 53% female, 47% male) from HIV clinics in Harare, Zimbabwe and Lusaka, Zambia
  • Intervention: 20,000 IU weekly vitamin D3 and 500 mg daily calcium carbonate for 48 weeks vs placebo
  • TBLH-BMD Z score at 48 weeks: intervention mean -1.53 (SD 1.18) vs control -1.56 (1.12)
  • Adjusted mean difference in TBLH-BMD Z score: -0.04 (95% CI -0.01 to 0.09)
  • Outcomes available for 751 (89%) participants at 48 weeks

High-dose vitamin D3 and calcium supplementation did not significantly improve lumbar spine bone mineral apparent density Z score overall.

  • LS-BMAD Z score at 48 weeks: intervention mean -0.64 (SD 1.17) vs control -0.71 (SD 1.16)
  • Adjusted mean difference in LS-BMAD Z score: -0.05 (95% CI -0.01 to 0.12)
  • Analysis adjusted for country and baseline value of the measure using linear regression

Among participants with vitamin D insufficiency at baseline, the intervention was associated with a significantly higher lumbar spine bone mineral apparent density Z score.

  • 639 of 842 participants (76%) were vitamin D insufficient at baseline, defined as 25[OH]D <75 nmol/L
  • Adjusted mean difference in LS-BMAD Z score among vitamin D insufficient participants: 0.09 (95% CI 0.02 to 0.16)
  • Interaction p-value for LS-BMAD subgroup: pinteraction=0.025
  • Adjusted mean difference in TBLH-BMD Z score among vitamin D insufficient participants: 0.06 (95% CI 0.00 to 0.11), pinteraction=0.15

Bone mineral density Z scores in this HIV-positive adolescent population were substantially lower than population norms at baseline.

  • Mean TBLH-BMD Z score in the control arm at 48 weeks was -1.56 (SD 1.12), indicating substantially reduced bone density relative to age- and sex-matched norms
  • Mean LS-BMAD Z score in the control arm at 48 weeks was -0.71 (SD 1.16)
  • Participants were peripubertal individuals aged 11-19 years on ART for at least 6 months

No drug-related severe adverse events were observed with the high-dose vitamin D3 and calcium carbonate supplementation regimen.

  • Intervention consisted of 20,000 IU weekly vitamin D3 and 500 mg daily calcium carbonate
  • Trial duration was 48 weeks
  • No statistical evidence of interaction was found in other pre-specified subgroups including country, age-group, sex, pubertal stage, calcium intake, tenofovir disoproxil fumarate use, and in a post-hoc subgroup analysis by viral suppression

The study population had a high prevalence of vitamin D insufficiency at baseline.

  • 639 of 842 participants (76%) had vitamin D insufficiency, defined as 25[OH]D <75 nmol/L
  • Participants were recruited from HIV clinics in sub-Saharan Africa (Harare, Zimbabwe and Lusaka, Zambia)
  • All participants had perinatally acquired HIV and were on antiretroviral therapy for at least 6 months

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Citation

Ferrand R, Dzavakwa N, Bandason T, Chisenga M, Filteau S, Kranzer K, et al.. (2026). Impact of high-dose vitamin D and calcium carbonate supplementation on bone density in adolescents living with HIV: a randomised, placebo-controlled trial.. The Lancet. Child &amp; adolescent health. https://doi.org/10.1016/S2352-4642(25)00301-3