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临床试验/NCT02662491
NCT02662491已完成不适用

Effects of Vitamin D and Calcium Supplementation on Health of UAE Citizens

United Arab Emirates University1 个研究点 分布在 1 个国家目标入组 545 人开始时间: 2017年1月最近更新:
适应症
干预措施

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

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

Experimental

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

Placebo Comparator

daily placebo tablet for 6 months

干预措施: Placebo (Dietary Supplement)

Calcium supplement

Experimental

daily oral calcium (600 mg) for 6 months

干预措施: Calcium (Dietary Supplement)

vitamin D supplement

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Salah Gariballa

Professor

United Arab Emirates University

研究点 (1)

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