RecruitingPhase 4NCT06537115

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

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


Sponsor

Zhejiang Provincial People's Hospital

Enrollment

450 participants

Start Date

Jun 16, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Eldecalcitol, a behavioral approach called exercise, and others for people with sarcopenia. The study is currently recruiting participants at 5 locations. People eligible for this study include aged 30 Years and older.

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

BEHAVIORALexercise

progressive resistance exercise

DIETARY_SUPPLEMENTwhey protein powder

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.

DRUGEldecalcitol

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


Locations(5)

The First People's Hospital of Chun'an County

Hangzhou, Zhejiang, China

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

Huzhou Nanxun District People's Hospital

Huzhou, Zhejiang, China

Xianju People's Hospital

Taizhou, Zhejiang, China

Dinghai Central Hospital of Zhoushan City

Zhoushan, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT06537115


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