Effect of Vitamin D Supplementation on Skeletal Muscle Function and Quality of Life in Patients With Chronic Intestinal Failure/Insufficiency: A Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Muscle function status
研究概览
简要总结
Eligible patients were randomized into two groups: Vitamin D group and Control group. Control group: received placebo plus standard care, no additional vitamin D intervention therapy. Vitamin D group: In addition to the standard care, additional intramuscular injection of vitamin D2 was given once every two weeks, each dose of 600,000 units, and the treatment lasted for 12 weeks.
The primary and secondary outcomes will be collected.
详细描述
Eligible patients with chronic intestinal failure/insufficiency were randomly assigned to one of two groups, Vitamin D group and Control group. Control group: received placebo plus standard care, no additional vitamin D intervention therapy. Vitamin D group: In addition to the conventional treatment, additional intramuscular injection of vitamin D2 was given once every two weeks, each dose of 600,000 units, and the treatment lasted for 12 weeks.
The primary and secondary outcomes will be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent was obtained from patients or their legal representatives for participation in this study
- •Patients 18 years of age or older, under 70 years of age, chronic intestinal failure/insufficiency
- •Serum 25(OH)D level < 30.0 ng/ml
- •Vital signs are stable
排除标准
- •Those who did not meet the inclusion criteria, or who were deemed unfit by their physician to participate in this study
- •Primary hypothyroidism or parathyroidism
- •Patients suffering from allergic diseases, are allergic, have a history of drug sensitivity similar to the structure of the study drug
- •Patients with primary diabetes
- •Patients with mental illness, inability to cooperate or consciousness disorders
- •Patients with contraindications of experimental drugs
- •Patients with a suspected or confirmed history of substance abuse
- •Immune deficiency, use of immunosuppressants and hormones
- •Pregnant and lactating women
- •Have taken any vitamin D supplements in the last 6 months
- •Have taken any medication in the last 6 months that affects vitamin D metabolism (e.g., phenytoin, phenobarbital, rifampicin)
- •Patients who participated in a drug trial (including the drug in the trial) within 3 months before the trial
- •Sponsors or investigators directly involved in the trial or their family members
- •The researcher believes that there is any reason not to be accepted
研究组 & 干预措施
Vitamin D
Experimental group: In addition to conventional treatment, additional intramuscular injection of vitamin D2 was given once every two weeks, each dose of 600,000 units, and the treatment lasted for 12 weeks.
干预措施: Vitamin D (Drug)
结局指标
主要结局
Muscle function status
时间窗: up to 12 weeks
Including hand grip strength(kg); Appendicular skeletal muscle mass index (ASMI) = limb muscle mass (kg)/height (m)2；6 meters walking speed(m/s)
Quality of life score
时间窗: up to 12 weeks
Quality of life was assessed using the SF-36 score from the date of randomization until the end of the 12-week intervention weeks. SF-36 consists of eight dimensions, each of which is measured on a scale of 0-100, with higher scores indicating a better quality of life.
次要结局
- Number of participants with treatment-related adverse events(up to 12 weeks)
- Serum vitamin D levels(up to 12 weeks)
- Nutritional status indicators(up to 12 weeks)
- Hepatic and renal function(up to 12 weeks)
- Bone mineral density(up to 12 weeks)
- Thyroid and parathyroid-related hormones(up to 12 weeks)
研究者
Wang Xinying
Prof
Jinling Hospital, China