Clinical Intervention of Idecalcitol Combined With Whey Protein Powder and Exercise for Sarcopenia
NCT ID: NCT06537115
Last Updated: 2024-08-05
Study Results
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Basic Information
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RECRUITING
PHASE4
450 participants
INTERVENTIONAL
2024-06-16
2027-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
exercise
progressive resistance exercise
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.
exercise
progressive resistance exercise
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.
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.)
exercise
progressive resistance exercise
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.
Eldecalcitol
Eldecalcitol soft gel capsules are taken at an oral dose of 0.75μg once a day for 12 consecutive weeks.
Interventions
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exercise
progressive resistance exercise
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.
Eldecalcitol
Eldecalcitol soft gel capsules are taken at an oral dose of 0.75μg once a day for 12 consecutive weeks.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
30 Years
ALL
No
Sponsors
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Zhejiang Provincial People's Hospital
OTHER
Responsible Party
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Principal Investigators
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Jianfang Ni, bachelor
Role: PRINCIPAL_INVESTIGATOR
Zhejiang Provincial People's Hospital
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Yunsheng Li, Bachelor
Role: primary
Haiyang Tang, Master
Role: primary
Hui Wu, Doctor
Role: primary
Kairui Deng, Bachelor
Role: primary
References
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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.
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.
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.
Other Identifiers
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KY2024041
Identifier Type: -
Identifier Source: org_study_id
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