Actively Recruiting

Phase 4
Age: 30Years +
All Genders
NCT06537115

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

Led by Zhejiang Provincial People's Hospital · Updated on 2024-08-05

450

Participants Needed

5

Research Sites

154 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 30Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 30 or above
  • Diagnosed with sarcopenia according to AWGS criteria
  • Able to walk and willing to follow the comprehensive intervention plan
  • Patient and family agree to participate and sign informed consent
Not Eligible

You will not qualify if you...

  • Resting systolic blood pressure over 200 mmHg or diastolic blood pressure over 100 mmHg
  • Severe heart disease such as moderate to severe aortic valve stenosis, acute pericarditis, acute myocarditis, myocardial infarction, or uncontrollable arrhythmia
  • Acute stroke within the past 2 years
  • Severe airway obstruction
  • Lower limb fractures in the past year or upper limb fractures in the past 6 months
  • Hypercalcemia (corrected albumin serum calcium over 2.60 mmol/L)
  • Active malignant tumors
  • Chronic kidney disease stage 5
  • Mental illness or severe cognitive impairment
  • Long-term immobilization
  • Other diseases interfering with evaluation of muscle mass, strength, or physical function
  • Unable to cooperate with treatment
  • Life expectancy less than 6 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

The First People's Hospital of Chun'an County

Hangzhou, Zhejiang, China

Actively Recruiting

2

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

Actively Recruiting

3

Huzhou Nanxun District People's Hospital

Huzhou, Zhejiang, China

Actively Recruiting

4

Xianju People's Hospital

Taizhou, Zhejiang, China

Actively Recruiting

5

Dinghai Central Hospital of Zhoushan City

Zhoushan, Zhejiang, China

Actively Recruiting

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Research Team

J

Jianfeng Tu, Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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