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临床试验/NCT03228862
NCT03228862Unknown4 期

Optimal Initial and Maintenance Doses of Ergocalciferol Supplementation for Treatment of Hypovitaminosis D in Thai Adults: A Randomized, Double-blinded Dose-comparison Study

Chulalongkorn University1 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2017年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
360
试验地点
1
主要终点
serum 25OHD phase 1

研究概览

简要总结

To investigate the optimal initial and maintenance doses of vitamin D2 supplementation for the treatment of vitamin D insufficiency in Thai adults, and to determine the prevalence of and risk factors for hypovitaminosis D among Thai adults.

详细描述

A double-blinded prospective, randomized study undertaken at outpatient clinic of King Chulalongkorn Memorial Hospital. The patients with vitamin D insufficiency were included and divided into three groups according to their initial 25OHD concentrations. Patients are randomly assigned to receive vitamin D2 40000, 60000 or 80000 IU once weekly. Serum 25(OH)D levels are measured at 12 weeks after vitamin D2 supplemetaiton. The patients with 25OHD more than 30ng/mL are enroll into the maintenance phase of the study and are randomly assigned to receive vitamin D2 20000 or 40000 IU once weekly for another 12 months. The 25OHD concentration are measure again at the end of the study.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Adult age ≥ 15 years
  • BMI 18 - 35 kg/m2
  • Serum 25(OH)D < 30ng/ml

排除标准

  • Hypercalcemia, nephrolithiasis, or fractures
  • Hepatic disease
  • Kidney disease
  • Granulomatous disease
  • Currently supplemented with vitamin D

研究组 & 干预措施

D40000

Experimental

Patients are randomly assigned to receive Ergocalciferol 40000 IU once weekly

干预措施: Ergocalciferol (Drug)

D60000

Experimental

Patients are randomly assigned to receive Ergocalciferol 60000 IU once weekly

干预措施: Ergocalciferol (Drug)

D80000

Experimental

Patients are randomly assigned to receive Ergocalciferol 80000 IU once weekly

干预措施: Ergocalciferol (Drug)

结局指标

主要结局

serum 25OHD phase 1

时间窗: 12 weeks

serum 25OHD concentration after initial vitamin D2 supplemetaiton

次要结局

未报告次要终点

研究者

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

Lalita Wattanachanya, MD

Assist Prof.

Chulalongkorn University

研究点 (1)

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