RecruitingPhase 2Phase 3ACTRN12619000636156

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


Sponsor

Western Health

Enrollment

88 participants

Start Date

May 11, 2021

Study Type

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

Sex: Both males and femalesMin Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether a supplement combination of vitamin D3 and beta-hydroxy-beta-methylbutyrate (HMB) can help older adults with osteosarcopenia — a condition where both bone density and muscle mass and strength are reduced simultaneously, dramatically increasing the risk of falls and fractures. There are currently no approved drug treatments specifically for osteosarcopenia, and supplements may offer a safe, accessible option. Men and postmenopausal women aged 65 and over who have both low muscle strength and reduced bone density (confirmed by grip strength measurement, walking speed test, and bone density scan) will be randomly assigned to take either vitamin D3 plus HMB or vitamin D3 plus placebo daily for 24 weeks. Physical function, muscle size and strength, and bone health markers will be assessed at baseline, 12 weeks, 24 weeks, and 36 weeks. You may be eligible if you are a man or postmenopausal woman aged 65 or over with self-reported mobility limitations, low grip strength, slow walking speed, and reduced bone density on a DXA scan. A wide range of conditions may exclude you, including recent fractures, Parkinson's disease, uncontrolled diabetes, active cancer, inflammatory conditions like rheumatoid arthritis, gastrointestinal malabsorption conditions, and certain medications affecting muscle mass. This Phase 2/3 study is run through Western Health.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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-be

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.


Locations(1)

Sunshine Hospital - St Albans

VIC, Australia

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