Clinical trial NCT06537115: Clinical Intervention of Idecalcitol Combined With Whey Protein Powder and Exercise for Sarcopenia
Official title: Clinical Intervention of Idecalcitol Combined With Whey Protein Powder and Exercise for Sarcopenia：a RCT Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Sarcopenia
Keywords: Sarcopenia
intervention
idecalcitol
whey protein powder
exercise
Lead sponsor: Zhejiang Provincial People's Hospital
Sponsor class: OTHER
First posted: 2024-08-05
Enrollment: 450
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: muscle mass
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Grip strength
timeFrame: up to 24 weeks
measure: 6-meter walking speed
timeFrame: up to 24 weeks
measure: incidence of adverse reactions
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First People's Hospital of Chun'an County
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
city: Huzhou
country: China
facility: Huzhou Nanxun District People's Hospital
state: Zhejiang
city: Taizhou
country: China
facility: Xianju People's Hospital
state: Zhejiang
city: Zhoushan
country: China
facility: Dinghai Central Hospital of Zhoushan City
state: Zhejiang
Study officials:
affiliation: Zhejiang Provincial People's Hospital
name: Jianfang Ni, bachelor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen LK, Woo J, Assantachai P, Auyeung TW, Chou MY, Iijima K, Jang HC, Kang L, Kim M, Kim S, Kojima T, Kuzuya M, Lee JSW, Lee SY, Lee WJ, Lee Y, Liang CK, Lim JY, Lim WS, Peng LN, Sugimoto K, Tanaka T, Won CW, Yamada M, Zhang T, Akishita M, Arai H. Asian Working Group for Sarcopenia: 2019 Consensus Update on Sarcopenia Diagnosis and Treatment. J Am Med Dir Assoc. 2020 Mar;21(3):300-307.e2. doi: 10.1016/j.jamda.2019.12.012. Epub 2020 Feb 4.
citation: Cruz-Jentoft AJ, Sayer AA. Sarcopenia. Lancet. 2019 Jun 29;393(10191):2636-2646. doi: 10.1016/S0140-6736(19)31138-9. Epub 2019 Jun 3.
citation: Maeda K, Imatani J, Moritani S, Kondo H. Effects of eldecalcitol alone or a bone resorption inhibitor with eldecalcitol on bone mineral density, muscle mass, and exercise capacity for postmenopausal women with distal radius fractures. J Orthop Sci. 2022 Jan;27(1):139-145. doi: 10.1016/j.jos.2020.11.009. Epub 2020 Dec 19.