Muscle Loss Prevention: New Hope with Vitamin D? Eldecalcitol and Sarcopenia

This study in The Lancet, Healthy Longevity, investigated whether eldecalcitol (an active form of vitamin D) could prevent sarcopenia (loss of muscle mass and strength) in adults with prediabetes. The authors found that eldecalcitol treatment reduced the incidence of sarcopenia compared to placebo. They also found that eldecalcitol treatment did not cause any serious side effects. These findings suggest that eldecalcitol may be a potential treatment for preventing sarcopenia in adults with prediabetes. More studies are needed to confirm these findings.

Key Points:

• The study was a randomized, double-blind, placebo-controlled, multicenter trial conducted in Japan.

• Participants: A total of 1094 individuals (548 in the eldecalcitol group and 546 in the placebo group) were included.

• Primary Endpoint: The primary endpoint was sarcopenia incidence over a 3-year period.

• Definition of Sarcopenia:

  • Weak handgrip strength: <28 kg for men and <18 kg for women.

  • Low appendicular skeletal muscle index: <7.0 kg/m2 for men and <5.7 kg/m2 for women (measured using bioelectrical impedance analysis).

• Hypercalcaemia Criterion:

  • Usual threshold: 10.4 mg/dL (2.6 mmol/L) or higher.

  • Discontinuation threshold: 11.0 mg/dL or higher.

• Eldecalcitol treatment demonstrated a statistically significant preventive effect on sarcopenia incidence:

  • Eldecalcitol group: 25 participants (4.6%)

  • Placebo group: 48 participants (8.8%)

  • Hazard ratio: 0.51 (95% CI 0.31 to 0.83, p=0.0065).

• Adverse Events: The incidence of adverse events did not differ significantly between the two groups.

Interpretation:

• The study suggests that eldecalcitol has the potential to prevent the onset of sarcopenia among individuals with prediabetes.

• Eldecalcitol may achieve this by increasing skeletal muscle volume and strength while reducing body fat mass after a median follow-up of 2.9 years.

A recent study investigated whether eldecalcitol, an active form of vitamin D, could prevent sarcopenia in adults with prediabetes. Sarcopenia is characterized by progressive muscle loss, weakness, and reduced physical function. It increases the risk of falls, fractures, and mortality, especially in older adults.

Background:

• Prediabetes is a condition marked by higher than-normal blood sugar levels but not high enough for a type 2 diabetes diagnosis.

• Observational studies suggest a link between low vitamin D levels and increased sarcopenia risk.

• Vitamin D supplementation studies have yielded mixed results on muscle mass and strength.

Study Design:

• This was a randomized, double-blind, placebo-controlled trial involving 1094 participants from Japan.

• Participants were divided into two groups: one receiving eldecalcitol (0.75 μg daily) and the other receiving a placebo.

• The primary outcome was sarcopenia development after 3 years, defined by low muscle strength and low muscle mass.

• Secondary outcomes included falls, changes in handgrip strength, and body composition changes (fat mass, lean mass, and muscle mass).

Participant Selection:

• Men and women aged 30 or older with prediabetes but without existing sarcopenia were included.

• Prediabetes was defined based on specific blood sugar level criteria.

• Sarcopenia was defined by low muscle strength and mass as per the Asian Working Group for Sarcopenia 2019 criteria.

Randomization and blinding:

• Participants were randomly assigned to either the eldecalcitol or placebo groups in a 1:1 ratio.

• Both groups received pills that looked identical to maintain blindness.

• A central randomization method ensured fairness in group allocation.

• The assignment list was kept confidential to preserve confidentiality, except for emergencies.

Procedures:

• Participants visited clinics every 3 months for various measurements.

• These included weight, waist circumference, handgrip strength, and body composition using a specialized device.

• Blood tests for vitamin D levels were also conducted.

Outcomes:

• The main outcome of interest was sarcopenia development within 3 years.

• Secondary outcomes included:

  • Falls (defined as unintentionally coming to rest on the ground): This data was collected retrospectively.

  • Changes in handgrip strength.

  • Changes in body composition (fat mass index, lean mass index, and skeletal muscle index).

Subgroup Analysis:

• Researchers planned to analyze the effects of eldecalcitol within subgroups defined by various factors that might influence sarcopenia risk. These factors included age, sex, body fat/muscle composition, and baseline vitamin D levels.

Key Findings:

• Eldecalcitol treatment significantly reduced sarcopenia incidence compared to placebo (4.6% vs. 8.8%).

• Eldecalcitol increased muscle strength and mass compared to a placebo.

• No significant difference in side effects between the groups was observed.

Limitations:

• The study only included people with prediabetes, so the results may not apply to the general population.

• The follow-up period was 3 years, and longer studies are needed for confirmation.

Future Directions:

• Larger trials are needed to confirm these findings in a broader population.

• The effects of eldecalcitol on other health aspects in older adults warrant investigation.

Overall Significance:

This study provides the first strong evidence that an active form of vitamin D can help prevent sarcopenia in adults with prediabetes. Eldecalcitol may offer a new approach to managing sarcopenia and its associated health problems in this population. More research is needed to solidify these findings and explore wider applications.

Additional Notes:

• The study was part of a larger research project (DPVD trial) investigating diabetes prevention in Japan.

• Participants with existing sarcopenia were excluded from this specific sarcopenia sub-study.

• A detailed description of the randomization process and outcome definitions is available in the original research article (accessible through scientific databases).

Journal Reference
Kawahara, T., Suzuki, G., Mizuno, S., Tominaga, N., Toda, M., Toyama, N., Inazu, T., Kawahara, C., Okada, Y., & Tanaka, Y. (2024). Active vitamin D treatment in the prevention of sarcopenia in adults with prediabetes (DPVD ancillary study): a randomised controlled trial. The lancet. Healthy longevity, 5(4), e255–e263. https://doi.org/10.1016/S2666-7568(24)00009-6

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