Effect of HMB and vitamin D supplementation on osteosarcopenia in older persons
A randomised, double-blind, placebo-controlled trial to determine the effect of vitamin D alone or in combination with HMB on osteosarcopenia in older persons
Western Health
88 participants
May 11, 2021
Interventional
Conditions
Summary
The purpose of this study is to determine the efficacy of vitamin D3 with or without HMB on the physical function, skeletal muscle mass, strength, bone turnover and bone microarchitecture in community-dwelling men and women aged 65 years with osteosarcopenia. This is a single-centre randomised, double-blind, placebo-controlled study design with approximately 88 osteosarcopenic patients randomised to daily oral treatments: vitamin D3 (1,000 IU/d) plus HMB or placebo in tablet form. The study will consist of a 24-week treatment period followed by a 12-week follow-up period. Assessments will be performed at the time of randomisation and at Weeks 12, 24 and 36.
Eligibility
Plain Language Summary
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Interventions
This is a single-centre randomised, double-blind, placebo-controlled study design with approximately 88 osteosarcopenic patients randomised to daily treatments: vitamin D3 plus Calcium Beta-hydroxy-beta-methylbutyrate (Ca-HMB) or vitamin D3 alone (placebo). The study will consist of a 24-week treatment period followed by a 12-week follow-up period. Assessments will be performed at the time of randomisation and at Weeks 12, 24 and 36. After screening, eligible patients will be randomised in a 1:1 ratio to receive two daily treatments of two tablets (at breakfast and lunch) containing vitamin D3 (250 IU/tablet) plus Ca-HMB (750 mg/tablet) or placebo (vitamin D3 (250 IU/tablet). Subjects will be assigned to one of the following 2 treatment arm to receive oral doses of the following: Arm 1 - vitamin D3 (1,000 IU/d) plus Ca-HMB (3g/day) Arm 2 - vitamin D3 (1,000 IU/d) alone (placebo) Adherence will be monitored through unused product treatment return to the Clinical Trials Pharmacy.
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ACTRN12619000636156