Is Vitamin D Insufficiency and Deficiency Associated With Antepartum and Postpartum Depression?
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 151
- 试验地点
- 1
- 主要终点
- Antepartum and Postpartum Depressive symptoms
研究概览
简要总结
Our primary aim is to evaluate whether Vitamin D deficiency causes depressive symptoms in antepartum and postpartum depression and whether early correction of Vitamin D deficiency improves these symptoms.
Our secondary aims evaluate maternal and fetal outcomes including antepartum, intrapartum, and immediate postpartum complications. We are also evaluating the effectiveness of a common vitamin D treatment regimen used outside of pregnancy.
详细描述
Our study recruitment will be at a single center in our pregnant private and clinic population. We will recruit eligible pregnant women 20 weeks 0 days or less. On study entry, patients will complete a demographic survey, vitamin D exposure survey, and an Edinburgh Postnatal Depression Score (EPDS) questionnaire. Baseline vitamin D levels will be obtained using a 25 OH D (vitamin D) assay.
Women found to be vitamin D deficient/insufficient will be approached for randomization to vitamin D3 (Cholecalciferol) 50,000 IU/week x 8 weeks + prenatal vitamin versus placebo + prenatal vitamin. A repeat 25 OH D sample plus a vitamin D exposure and EPDS questionnaires will be obtained between 24-28 weeks gestation upon completing treatment. All patients will then be kept on maintenance vitamin D until delivery (total vitamin D 800IU/day which includes prenatal vitamin). Delivery 25 OH D samples will be collected on all women. At delivery, these women will also complete vitamin D exposure and EPDS questionnaires. Maternal and fetal outcome data will be collected on all patients.
As for vitamin D sufficient patients, they will be followed with vitamin D exposure and EPDS questionnaires at 24-28 weeks and delivery. A 25 OH D sample will be obtained at delivery for these women. Maternal and fetal outcome data will be obtained.
For vitamin D deficient women declining randomization, they will be given vitamin D repletion based on their preference after counseling. We will continue to follow their questionnaires and outcomes similarly to the vitamin D sufficient group.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Evaluation at Roosevelt Hospital (Receiving prenatal care with St Luke's Roosevelt Hospital center private physicians and clinic) by 20w0d gestation.
- •Planned delivery at Roosevelt Hospital Labor & Delivery
- •English or Spanish speaking
排除标准
- •Non-english or non-spanish speaking
- •Currently on anti-depressants/mood stabilizing medications
- •Medical comorbidities affecting vitamin D absorption or metabolism:Bone disease (osteoporosis, osteomalacia); Malabsorption disorders (cystic fibrosis, inflammatory bowel disease, roux-en-y bariatric surgery); Chronic kidney disease; Severe liver disease; Granuloma forming disorders (active tuberculosis, sarcoidosis);Parathyroid disease; Lymphoma; HIV on HAART medication; anti-seizure medications.
研究组 & 干预措施
Vitamin D3 (cholecalciferol) treatment
50,000 IU vitamin D3 (cholecalciferol) tablet weekly x 8 weeks plus prenatal vitamin (400 IU vitamin D)
干预措施: Vitamin D3 (Cholecalciferol) (Dietary Supplement)
Vitamin D placebo
Placebo tablet (appearance same as active vitamin D) plus prenatal vitamin (400IU vitamin D)
干预措施: Placebo (Other)
结局指标
主要结局
Antepartum and Postpartum Depressive symptoms
时间窗: 9 months
We will be using an Edinburgh Postnatal Depression Scale (EPDS) questionnaire to monitor depressive symptoms.
次要结局
- Fetal morbidities(Antepartum and delivery)
- Maternal morbidities(Antepartum and Delivery)