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NCT Number: NCT06537115

Clinical Intervention of Idecalcitol Combined With Whey Protein Powder and Exercise for Sarcopenia

This clinical trial is a multicenter, single-blind, prospective, randomized controlled clinical application study. Subjects who met the trial criteria and signed the informed consent form were randomly divided into a control group, an experimental group 1, and an experimental group 2. After enrollment, the control group underwent a comprehensive assessment of their underlying conditions by professional physicians and received routine interventions, including basic nutritional intervention program guidance, progressive resistance exercise intervention program guidance, safety precautions, and symptomatic treatment for different complications, for a total intervention period of 24 weeks. The experimental group 1, in addition to the interventions provided to the control group, received whey protein powder supplementation for 12 weeks. The experimental group 2, on the other hand, received both whey protein powder and eldecalcitol supplementation on top of the interventions given to the control group, also for 12 weeks. The entire intervention period lasted for 24 weeks. Through regular general assessments, blood tests, measurements of muscle mass, muscle strength, and physical function, as well as analyses of negative adverse events, statistical methods were employed to evaluate the safety and efficacy of the comprehensive intervention methods for sarcopenia.

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Key information

Conditions

Sarcopenia Atrophy Behavior Motor Activity Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The First People's Hospital of Chun'an County, Hangzhou, Zhejiang, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise

Behavioral

progressive resistance exercise

Whey protein powder

Dietary Supplement

The protein intake is 60 grams per day, taken in three divided doses for 12 consecutive weeks. Attention should be paid to monitoring liver and kidney function, and the dosage of protein powder should be adjusted according to the condition of the patient.

Eldecalcitol

Drug

Eldecalcitol soft gel capsules are taken at an oral dose of 0.75μg once a day for 12 consecutive weeks.

Primary outcomes

  1. muscle mass

    Time frame: up to 24 weeks

    The DXA equipment is used to detect the muscle mass.

Secondary outcomes

  1. Grip strength

    Time frame: up to 24 weeks

    Using a spring dynamometer, stand upright with the elbow joint fully extended, and use the muscle strength of the dominant hand to record the maximum reading (in kg) from three trials.

  2. 6-meter walking speed

    Time frame: up to 24 weeks

    Record the time required to walk 6 meters from the starting point at a normal speed without decelerating, and use the average result of 3 trials as the recorded walking speed (in m/s).

  3. incidence of adverse reactions

    Time frame: up to 24 weeks

    The number of patients with adverse events within a unit time / the total number of patients in the experimental or control group during the same period * 100%.

Study contacts

Contact information is provided by the study sponsor or research team.

Jianfeng Tu, Doctor

CONTACT

[email protected]

+86 15925669920

Sponsors and collaborators

Lead sponsor

Zhejiang Provincial People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Aug 5, 2024
Registry last updated
Aug 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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