ACTRN12621000597897终止未知
Effect of vitamin D supplementation on immune cells of healthy adults and adults with multiple sclerosis
Alfred Hospital0 个研究点目标入组 3 人开始时间: 2021年5月19日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 终止
- 发起方
- 入组人数
- 3
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •Aged between 18 and 65 years old inclusive
- •No Vitamin D supplementation for at least 1 month prior
- •Be willing to avoid open-label Vitamin D supplementation and external serum Vitamin D testing for the duration of the study
- •Be willing to avoid the use of sunbeds
- •Not currently pregnant or planning to become pregnant during the study period, and willing to use effective contraceptive methods for the duration of the study
- •Be able and willing to comply with all study procedures
- •Be able to give informed consent and sign the informed consent form
- •Additional inclusion criteria for healthy participants are:
- •No diagnosis of MS or CIS, or significant chronic disease
- •Additional inclusion criteria for participants with MS are:
- •Relapsing-remitting MS diagnosed within the previous 10 years, meeting McDonald criteria for the diagnosis of MS
- •Either on no DMT or on natalizumab prior to and during the study period
- •Diagnosed and managed by a neurologist
排除标准
- •Currently pregnant or breastfeeding
- •A history of primary hyperparathyroidism or any other condition causing hypercalcaemia
- •A history of sarcoidosis
- •A history of renal calculi
- •A history of treated osteoporosis or any other condition requiring treatment with calcium, Vitamin D, bisphosphonates, strontium ranelate, denosumab, raloxifene, calcitriol or teriparetide
- •Hypercalcaemia, abnormal eGFR (<60 mL/min/1.73m2) or an elevated uric acid laboratory value on screening blood tests
- •Other neurological, psychiatric or other disease comorbidities which, in the opinion of the investigator, could impair capacity to provide informed consent, interfere with study compliance, or impair the participant’s ability to comply with study protocol
- •Current enrolment in another drug interventional trial
研究者
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