Is Vitamin D Insufficiency and Deficiency Associated With Antepartum and Postpartum Depression?
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02272387|
Recruitment Status : Terminated (Low enrollment and limited research staffing)
First Posted : October 22, 2014
Last Update Posted : August 24, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Depression Postpartum Depression||Dietary Supplement: Vitamin D3 (Cholecalciferol) Other: Placebo||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||151 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Is Vitamin D Insufficiency and Deficiency Associated With Antepartum and Postpartum Depression?|
|Actual Study Start Date :||October 2014|
|Actual Primary Completion Date :||April 14, 2016|
|Actual Study Completion Date :||April 14, 2016|
Active Comparator: Vitamin D3 (cholecalciferol) treatment
50,000 IU vitamin D3 (cholecalciferol) tablet weekly x 8 weeks plus prenatal vitamin (400 IU vitamin D)
Dietary Supplement: Vitamin D3 (Cholecalciferol)
Placebo Comparator: Vitamin D placebo
Placebo tablet (appearance same as active vitamin D) plus prenatal vitamin (400IU vitamin D)
- Antepartum and Postpartum Depressive symptoms [ Time Frame: 9 months ]We will be using an Edinburgh Postnatal Depression Scale (EPDS) questionnaire to monitor depressive symptoms.
- Maternal morbidities [ Time Frame: Antepartum and Delivery ]Composite maternal complications: preeclampsia, GDM, delivery complications, chorioamnionitis, etc.
- Fetal morbidities [ Time Frame: Antepartum and delivery ]Composite outcomes: SGA, IUGR, low apgars, low cord gases, hydramnios, etc.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02272387
|United States, New York|
|Mount Sinai Roosevelt Hospital|
|New York, New York, United States, 10019|