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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02272387
• Other study ID #: 13-0223
• Status: Terminated
• Phase: N/A
• First received: October 16, 2014
• Last updated: August 23, 2017
• Start date: October 2014
• Est. completion date: April 14, 2016

Study information

• Verified date: August 2017
• Source: St. Luke's-Roosevelt Hospital Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 151
• Est. completion date: April 14, 2016
• Est. primary completion date: April 14, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Postpartum Depression

Intervention

Dietary Supplement:
• Vitamin D3 (Cholecalciferol)

Other:
• Placebo

Locations

Country	Name	City	State
United States	Mount Sinai Roosevelt Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
St. Luke's-Roosevelt Hospital Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antepartum and Postpartum Depressive symptoms	We will be using an Edinburgh Postnatal Depression Scale (EPDS) questionnaire to monitor depressive symptoms.	9 months
Secondary	Maternal morbidities	Composite maternal complications: preeclampsia, GDM, delivery complications, chorioamnionitis, etc.	Antepartum and Delivery
Secondary	Fetal morbidities	Composite outcomes: SGA, IUGR, low apgars, low cord gases, hydramnios, etc.	Antepartum and delivery