Is Vitamin D Insufficiency and Deficiency Associated With Antepartum and Postpartum Depression?

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Is Vitamin D Insufficiency and Deficiency Associated With Antepartum and Postpartum Depression?

Conditions
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Depression, Postpartum Depression

Intervention / Treatment
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* Dietary Supplement: Vitamin D3 (Cholecalciferol)
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vitamin D3 (cholecalciferol) treatment<br>50,000 IU vitamin D3 (cholecalciferol) tablet weekly x 8 weeks plus prenatal vitamin (400 IU vitamin D) | Dietary Supplement: Vitamin D3 (Cholecalciferol)<br> <br> |
| Placebo Comparator: Vitamin D placebo<br>Placebo tablet (appearance same as active vitamin D) plus prenatal vitamin (400IU vitamin D) | Other: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antepartum and Postpartum Depressive symptoms | We will be using an Edinburgh Postnatal Depression Scale (EPDS) questionnaire to monitor depressive symptoms. | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal morbidities | Composite maternal complications: preeclampsia, GDM, delivery complications, chorioamnionitis, etc. | Antepartum and Delivery | 
| Fetal morbidities | Composite outcomes: SGA, IUGR, low apgars, low cord gases, hydramnios, etc. | Antepartum and delivery |