Vitamin D Supplement to Women With Type 2 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 265
- 试验地点
- 1
- 主要终点
- Change in Center for Epidemiologic Studies Depression (CES-D) Score From Baseline (Month 0) to Month 6 for the High Dose Cohort Versus Low Dose Cohort
研究概览
简要总结
This is a randomized clinical trial (RCT) to determine the effectiveness of vitamin D3 supplementation on depressive symptoms, self-management, and blood pressure in approximately 180 adult women with type 2 diabetes who have significant depressive symptoms. Consenting adult women who are eligible to participate will be randomly assigned to either a weekly dose of 50,000 international units of vitamin D3 supplementation or a matching weekly active comparator of 5,000 international units of vitamin D3 for six months. Participants will complete approximately four in-person study visits and several telephone visits throughout the six month trial period, where the researchers will assess depressive symptoms, diabetes self-management, and systolic blood pressure.
详细描述
The primary aim of this study is to determine the effect of vitamin D supplementation on depressive symptoms, self-management, and systolic blood pressure compared to placebo. The hypothesis is that women receiving vitamin D supplementation will report fewer depressive symptoms, increased diabetes self- management mediated by depression improvement, and will have a lower systolic blood pressure compared to those taking placebo at three and six months follow-up.
The secondary aim is to explore the mechanistic effect of vitamin D supplementation on inflammatory biomarkers and their association with depression. Here, the hypothesis is that women receiving vitamin D supplementation will have a decrease in inflammatory biomarkers which will be associated with fewer depressive symptoms compared to those taking placebo at three and six months follow-up.
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
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women age 21 and older
- •Objective evidence of depressive symptoms at the screening and baseline visits
- •Diagnosis of type 2 diabetes currently being treated by a healthcare provider
- •Blood vitamin D level less than 32 nanograms-per-deciliter (32 ng/dl)
排除标准
- •Current alcohol or substance use disorder
- •Any unstable or severe psychiatric disease including diagnoses of schizophrenia, bipolar affective disorder, dementia, delirium, or other psychotic disorder
- •Severe complications of diabetes, such as blindness and/or amputation
- •Any malabsorption disorder, such as Crohn's disease and/or celiac sprue
- •Elevated serum calcium level deemed significant by the Principal Investigator
- •Use of 1,000 or more international units daily vitamin D 60 days before enrollment and unwillingness to discontinue vitamin D supplementation 30 days before enrollment.
- •Use of St. John's Wort and unwillingness to discontinue St. John's Wort three weeks prior to enrollment.
- •Participants who are pregnant, nursing, or planning to become pregnant during the study.
- •Baseline systolic blood pressure (SBP) greater than 160 millimeters of mercury (mmHG) or diastolic blood pressure (DBP) greater than 100 mmHG.
- •Other serious medical conditions (e.g., cancer, multiple sclerosis, etc.) deemed clinically significant by the Principal Investigator
研究组 & 干预措施
Vitamin D3
50,000 international units (IUs) weekly Vitamin D3
干预措施: Vitamin D3 (Drug)
Vitamin D3 comparator
5,000 international units (IUs) of a weekly Vitamin D3 comparator
干预措施: Vitamin D3 comparator (Drug)
结局指标
主要结局
Change in Center for Epidemiologic Studies Depression (CES-D) Score From Baseline (Month 0) to Month 6 for the High Dose Cohort Versus Low Dose Cohort
时间窗: Baseline and 6 months
The Center for Epidemiologic Studies Depression (CES-D) is a self-report questionnaire assessing frequency and severity of depression symptoms. Raw scores range from 0 to 60, where higher scores indicate worse mood. For each participant, her baseline CES-D score is subtracted from her month 6 CES-D score to create a CES-D change score.
次要结局
- Change in Diastolic Blood Pressure From Baseline (Month 0) to Month 6 for the High Dose Cohort Versus Low Dose Cohort(Baseline and 6 months)
- Change in Problem Areas in Diabetes (PAIDS) Score From Baseline (Month 0) to Month 6 for the High Dose Cohort Versus Low Dose Cohort(Baseline and 6 months)
- Change in Systolic Blood Pressure From Baseline (Month 0) to Month 6 for the High Dose Cohort Versus Low Dose Cohort(Baseline and 6 months)
研究者
Sue
Professor
Loyola University