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

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое exercise
  progressive resistance exercise
• Пищевая добавка 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.
• Препарат Eldecalcitol
  Eldecalcitol soft gel capsules are taken at an oral dose of 0.75μg once a day for 12 consecutive weeks.

Первичные конечные точки

• muscle mass [Срок оценки: up to 24 weeks]

Вторичные конечные точки (3)

• Grip strength [Срок оценки: up to 24 weeks]
• 6-meter walking speed [Срок оценки: up to 24 weeks]
• incidence of adverse reactions [Срок оценки: up to 24 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 5 центров

• The First People's Hospital of Chun'an County — Ханчжоу
• Zhejiang Provincial People's Hospital — Ханчжоу
• Huzhou Nanxun District People's Hospital — Huzhou
• Xianju People's Hospital — Taizhou
• Dinghai Central Hospital of Zhoushan City — Zhoushan

Публикации

• 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 PMID 32033882
• 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. PMID 31171417
• 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. PMID 33349543

Идентификаторы

NCT: NCT06537115 · KY2024041

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗