Effects of Vitamin D and Calcium Supplementation on Health of UAE Citizens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 545
- 试验地点
- 1
- 主要终点
- Muscle pains
研究概览
简要总结
The trial plan to determine whether a daily capsule containing vitamin D(3) (2000 IU), calcium (600 mg), both, or a placebo for 6 months in UAE citizens with evidence of vitamin D deficiency will lead to a clinical benefit. The proposed study will also determine the threshold of vitamin D and calcium intake or levels considered optimal for UAE citizen's health
详细描述
The proposed study is a two by two factorial, randomized controlled intervention trial. Following informed written consent of eligible subject's blood and urine samples will be taken for measurements of vitamin D, markers of bone turnover and related biochemical variables. Patients who have evidence of vitamin D deficiency will then be randomly assigned to receive daily vitamin D(3) (2000 IU), calcium (1000 mg), both, or a placebo for 6 months. All subjects will have a calcium and vitamin D rich food and other lifestyle modification advises during the study period. Patients will otherwise be managed according to standard practice. Clinical assessment that includes general and self-rated health, bone density, muscle strength, physical activity and dietary intakes will be performed at baseline, and repeated at 3, 6 and 12 months post-randomisation.
Information on other important variables likely to influence vitamin D status including age, reproductive & menopausal history, smoking, medications, adiposity, exposure to sunlight, dietary intake including supplements, skin pigmentation, chronic illness and medications will be collected and adjusted for during the analysis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double blind
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •biochemical evidence of vitamin D deficiency
排除标准
- •renal disease or stones or hypercalcaemia,
- •Use of calcium and/or vitamin D supplementation, bisphosphonates, steroid medications, hormones or diuretics.
研究组 & 干预措施
vitamin D and calcium
daily oral vitamin D(3) (2000 IU) and calcium (600 mg) for 6 months
干预措施: Vitamin D and calcium (Dietary Supplement)
Placebo
daily placebo tablet for 6 months
干预措施: Placebo (Dietary Supplement)
Calcium supplement
daily oral calcium (600 mg) for 6 months
干预措施: Calcium (Dietary Supplement)
vitamin D supplement
daily oral vitamin D(3) (2000 IU) for 6 months
干预措施: Vitamin D (Dietary Supplement)
结局指标
主要结局
Muscle pains
时间窗: 6 months
Muscle pains measured using a questionnaire
Muscle strength
时间窗: 6 months
Muscle strength measured using dynamometer
Vitamin D level
时间窗: 6 months
vitamin D level measured using liquid chromatography
次要结局
- Dietary calcium intake(6 months)
- Dietary vitamin D intake(6 months)
研究者
Salah Gariballa
Professor
United Arab Emirates University
