Evaluation of Vitamin D Supplementation Effects on Serum 25(OH)D3, PTH, Pro-inflammatory Biomarkers and Neurotransmitters Involved in Depression, and Depression Status in Depressive Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- significant change (mean±SD) in vitamin D status
研究概览
简要总结
Groups (intervention group receives 50000 IU vitamin D and control group receives placebo) through a random allocation. After 8 weeks, blood sample will be collected from each participant. The studied indices (inflammatory (IL-1β, IL-6, hs-CRP), PTH, platelet serotonin, serum oxytocin, serum 25(OH) D, depression status and anthropometry indices) will be evaluated at beginning and end of interventional period.
详细描述
In this double-blind randomized clinical trial, 60 patients aged 18-60y referred to Baharlou hospital with a history of mild to moderate depression diagnosed by a psychiatrist will be presented to the researcher. After receipt of a signed informed consent form, eligible patients will participate. A general demographic questionnaire will be completed by an interviewer. Individuals are randomly divided into intervention and control groups. A 10-ml venous blood sample will be collected from each participant. The intervention group receives 50000 IU of vitamin D every 2 weeks as vitamin D supplements for 8 weeks, provided monthly. The control group receives placebo. The drug schedule of both groups (if any) will be unchanged according to the prescribing physician. After 8 weeks, blood sample will be collected from each participant. The studied indices (inflammatory (IL-1β, IL-6, hs-CRP), PTH, platelet serotonin, serum oxytocin, serum 25(OH) D, depression status, anthropometry indices) will be evaluated at beginning and end of interventional period. Data will be analyzed by statistical tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age: 18 to 60 y
- •Having mild to moderate depression
排除标准
- •Having a history of heart infarction
- •Having a history of angina
- •Having a history of stroke
- •Having a history of kidney stones
- •Having a history of high blood pressure (systolic blood pressure higher than 174 or diastolic blood pressure higher than 104 mm Hg)
- •Having a history of liver disease
- •Having a history of hyperparathyroidism
- •Pregnancy and/or lactation
- •Reproductive-aged women (under 50 years old) who are not receiving adequate contraception
- •Consuming nutritional supplement containing vitamin D from 2 months ago
- •Not willing to continue the study
- •Failure to follow the Supplemental Program
研究组 & 干预措施
Intervention
vitamin D supplement every other week
干预措施: vitamin D supplement (Dietary Supplement)
control
Placebo every other week
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
significant change (mean±SD) in vitamin D status
时间窗: baseline and 8 weeks after intervention
The serum concentration of 25(OH) D (nmol/L) will be measured at baseline and 8 weeks after intervention. normal range is 25-162 nmol/L
次要结局
- significant change (mean±SD) in serum concentration of hs-CRP(baseline and 8 weeks after intervention)
- significant change (mean±SD) in platelet serotonin concentration (ng/10^9 platelets)(baseline and 8 weeks after intervention)
- significant change (mean±SD) in serum concentration of oxytocin (µU/mL)(baseline and 8 weeks after intervention)
- significant change (mean±SD) in serum concentration of IL-1β and IL-6.(baseline and 8 weeks after intervention)
- significant change (mean±SD) in serum concentration of bone biomarker(baseline and 8 weeks after intervention)
- significant change (mean±SD) in depression status(baseline and 8 weeks after intervention)
研究者
Tirang R. Neyestani, Ph.D.
Tirang R. Neyestani, Ph.D. Professor
National Nutrition and Food Technology Institute