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

Not Applicable

Terminated

• Conditions: Postpartum Depression; Depression
• Interventions: Dietary Supplement: Vitamin D3 (Cholecalciferol); Other: Placebo

• Registration Number: NCT02272387
• Lead Sponsor: St. Luke's-Roosevelt Hospital Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-16
• Study First Submitted QC: 2014-10-20
• Study First Posted: 2014-10-22
• Primary Completion: 2016-04-14
• Study Completion: 2016-04-14
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-23
• Last Update Posted: 2017-08-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 151

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D3 (cholecalciferol) treatment	Vitamin D3 (Cholecalciferol)	50,000 IU vitamin D3 (cholecalciferol) tablet weekly x 8 weeks plus prenatal vitamin (400 IU vitamin D)
Vitamin D placebo	Placebo	Placebo tablet (appearance same as active vitamin D) plus prenatal vitamin (400IU vitamin D)

Primary Outcome Measures

Name	Time	Method
Antepartum and Postpartum Depressive symptoms	9 months	We will be using an Edinburgh Postnatal Depression Scale (EPDS) questionnaire to monitor depressive symptoms.

Secondary Outcome Measures

Name	Time	Method
Fetal morbidities	Antepartum and delivery	Composite outcomes: SGA, IUGR, low apgars, low cord gases, hydramnios, etc.
Maternal morbidities	Antepartum and Delivery	Composite maternal complications: preeclampsia, GDM, delivery complications, chorioamnionitis, etc.

Trial Locations

Locations (1)

Mount Sinai Roosevelt Hospital; 🇺🇸 New York, New York, United States