Is Vitamin D Insufficiency and Deficiency Associated With Antepartum and Postpartum Depression?
Primary Purpose
Depression, Postpartum Depression
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vitamin D3 (Cholecalciferol)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Depression
Eligibility Criteria
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.
Sites / Locations
- Mount Sinai Roosevelt Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Vitamin D3 (cholecalciferol) treatment
Vitamin D placebo
Arm Description
50,000 IU vitamin D3 (cholecalciferol) tablet weekly x 8 weeks plus prenatal vitamin (400 IU vitamin D)
Placebo tablet (appearance same as active vitamin D) plus prenatal vitamin (400IU vitamin D)
Outcomes
Primary Outcome Measures
Antepartum and Postpartum Depressive symptoms
We will be using an Edinburgh Postnatal Depression Scale (EPDS) questionnaire to monitor depressive symptoms.
Secondary Outcome Measures
Maternal morbidities
Composite maternal complications: preeclampsia, GDM, delivery complications, chorioamnionitis, etc.
Fetal morbidities
Composite outcomes: SGA, IUGR, low apgars, low cord gases, hydramnios, etc.
Full Information
NCT ID
NCT02272387
First Posted
October 16, 2014
Last Updated
August 23, 2017
Sponsor
St. Luke's-Roosevelt Hospital Center
1. Study Identification
Unique Protocol Identification Number
NCT02272387
Brief Title
Is Vitamin D Insufficiency and Deficiency Associated With Antepartum and Postpartum Depression?
Official Title
Is Vitamin D Insufficiency and Deficiency Associated With Antepartum and Postpartum Depression?
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Terminated
Why Stopped
Low enrollment and limited research staffing
Study Start Date
October 2014 (Actual)
Primary Completion Date
April 14, 2016 (Actual)
Study Completion Date
April 14, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Luke's-Roosevelt Hospital Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Postpartum Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
151 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D3 (cholecalciferol) treatment
Arm Type
Active Comparator
Arm Description
50,000 IU vitamin D3 (cholecalciferol) tablet weekly x 8 weeks plus prenatal vitamin (400 IU vitamin D)
Arm Title
Vitamin D placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablet (appearance same as active vitamin D) plus prenatal vitamin (400IU vitamin D)
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D3 (Cholecalciferol)
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Antepartum and Postpartum Depressive symptoms
Description
We will be using an Edinburgh Postnatal Depression Scale (EPDS) questionnaire to monitor depressive symptoms.
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Maternal morbidities
Description
Composite maternal complications: preeclampsia, GDM, delivery complications, chorioamnionitis, etc.
Time Frame
Antepartum and Delivery
Title
Fetal morbidities
Description
Composite outcomes: SGA, IUGR, low apgars, low cord gases, hydramnios, etc.
Time Frame
Antepartum and delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Mount Sinai Roosevelt Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
12. IPD Sharing Statement
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Is Vitamin D Insufficiency and Deficiency Associated With Antepartum and Postpartum Depression?
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