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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Behavioral, Dietary supplement, Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 30
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
The First People's Hospital of Chun'an County
RECRUITING
Hangzhou
Zhejiang Provincial People's Hospital
RECRUITING
Hangzhou
Huzhou Nanxun District People's Hospital
RECRUITING
Huzhou
Xianju People's Hospital
RECRUITING
Taizhou
Dinghai Central Hospital of Zhoushan City
RECRUITING
Zhoushan
Contact Information
Primary
Jianfeng Tu, Doctor
tutu5800@163.com
+86 15925669920
Time Frame
Start Date: 2024-06-16
Estimated Completion Date: 2027-05-31
Participants
Target number of participants: 450
Treatments
Other: Control group
After enrollment, professional doctors will conduct a comprehensive assessment of their basic conditions and provide routine interventions, mainly including basic nutrition intervention program guidance, progressive resistance exercise intervention program guidance, safety protection advice, and symptomatic treatment for different complications, with a total intervention period of 24 weeks.
Other: experimental group 1
On the basis of the control group, whey protein powder was given to supplement for 12 weeks.60 grams of protein per day is 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.
Other: experimental group 2
On the basis of the control group, whey protein powder and eldecalcitol were given for supplementation for 12 weeks.~(Supplementing whey 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.~Supplementing eldecalcitol: eldecalcitol soft gel capsules are taken at an oral dose of 0.75μg once a day for 12 consecutive weeks.)
Related Therapeutic Areas
Sponsors
Leads: Zhejiang Provincial People's Hospital

This content was sourced from clinicaltrials.gov