NCT06537115 Clinical Intervention of Idecalcitol Combined With Whey Protein Powder and Exercise for Sarcopenia
| NCT ID | NCT06537115 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Zhejiang Provincial People's Hospital |
| Condition | Sarcopenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 450 participants |
| Start Date | 2024-06-16 |
| Primary Completion | 2026-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 450 participants in total. It began in 2024-06-16 with a primary completion date of 2026-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Jianfang Ni, bachelor
PRINCIPAL INVESTIGATOR
Zhejiang Provincial People's Hospital
Frequently Asked Questions
Who can join the NCT06537115 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, studying Sarcopenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06537115 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06537115 currently recruiting?
Yes, NCT06537115 is actively recruiting participants. Contact the research team at tutu5800@163.com for enrollment information.
Where is the NCT06537115 trial being conducted?
This trial is being conducted at Hangzhou, China, Hangzhou, China, Huzhou, China, Taizhou, China and 1 additional location.
Who is sponsoring the NCT06537115 clinical trial?
NCT06537115 is sponsored by Zhejiang Provincial People's Hospital. The principal investigator is Jianfang Ni, bachelor at Zhejiang Provincial People's Hospital. The trial plans to enroll 450 participants.