Combining Idecalcitol, Whey Protein, and Exercise to Treat Sarcopenia

Clinical Intervention of Idecalcitol Combined With Whey Protein Powder and Exercise for Sarcopenia：a RCT Trial

This study is testing whether combining a vitamin, whey protein, and exercise can help people with sarcopenia build muscle and improve their strength.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 450 (estimated)
• Ages: 30 Years and up
• Sex: All
• Sponsor: Zhejiang Provincial People's Hospital (Academic / other)
• Locations: 5 sites (Hangzhou, Zhejiang and 4 other locations)
• Trial ID: NCT06537115 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of idecalcitol combined with whey protein powder and exercise on patients with sarcopenia. Participants are randomly assigned to a control group receiving standard interventions or to experimental groups receiving additional whey protein or both whey protein and idecalcitol. The trial lasts for 24 weeks, focusing on improving muscle mass and function in individuals diagnosed with sarcopenia. The study aims to assess the efficacy of these combined interventions in enhancing patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 30 and above who meet the diagnostic criteria for sarcopenia and are able to participate in a comprehensive intervention plan.

Not a fit: Patients with severe cardiovascular issues, active malignancies, or other significant health conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve muscle strength and overall health in patients suffering from sarcopenia.

How similar studies have performed: Other studies have shown promising results with similar interventions for sarcopenia, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Age 30 or above;

  * Meeting the diagnostic criteria for sarcopenia according to the definition of AWGS; ③ Able to walk, willing to accept a comprehensive intervention plan, and guarantee to complete the treatment course; ④ Both patients and their families agree to participate in this study and sign the informed consent form.

Exclusion Criteria:

* Resting systolic blood pressure \> 200 mmHg or resting diastolic blood pressure \> 100 mmHg;

  * Severe heart disease: moderate to severe aortic valve stenosis, acute pericarditis, acute myocarditis, myocardial infarction, uncontrollable arrhythmia;

    * Acute stroke within the past 2 years;

      * Severe airway obstruction;

        * Lower limb fractures in the past 1 year or upper limb fractures in the past 6 months;

          * Hypercalcemia (corrected albumin serum calcium \> 2.60 mmol/L);

            * Active malignant tumors; ⑧ Chronic kidney disease stages 5;

              * Mental illness or severe cognitive impairment;

                * Long-term immobilization; ⑪ Other diseases that may interfere with the evaluation of muscle mass, muscle strength, and physical function; ⑫ Unable to cooperate with treatment due to other reasons; ⑬ Life expectancy less than 6 months.

Where this trial is running

Hangzhou, Zhejiang and 4 other locations

• The First People's Hospital of Chun'an County — Hangzhou, Zhejiang, China (Recruiting)
• Zhejiang Provincial People's Hospital — Hangzhou, Zhejiang, China (Recruiting)
• Huzhou Nanxun District People's Hospital — Huzhou, Zhejiang, China (Recruiting)
• Xianju People's Hospital — Taizhou, Zhejiang, China (Recruiting)
• Dinghai Central Hospital of Zhoushan City — Zhoushan, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Jianfang Ni, bachelor — Zhejiang Provincial People's Hospital
• Study coordinator: Jianfeng Tu, Doctor

Conditions Sarcopenia; intervention; idecalcitol; whey protein powder; exercise