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Trial record 47 of 400 for:    postpartum depression

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

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ClinicalTrials.gov Identifier: NCT02272387
Recruitment Status : Terminated (Low enrollment and limited research staffing)
First Posted : October 22, 2014
Last Update Posted : August 24, 2017
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Depression Postpartum Depression Dietary Supplement: Vitamin D3 (Cholecalciferol) Other: Placebo Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 151 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)
Other: Placebo



Primary Outcome Measures :
  1. Antepartum and Postpartum Depressive symptoms [ Time Frame: 9 months ]
    We will be using an Edinburgh Postnatal Depression Scale (EPDS) questionnaire to monitor depressive symptoms.


Secondary Outcome Measures :
  1. Maternal morbidities [ Time Frame: Antepartum and Delivery ]
    Composite maternal complications: preeclampsia, GDM, delivery complications, chorioamnionitis, etc.

  2. Fetal morbidities [ Time Frame: Antepartum and delivery ]
    Composite outcomes: SGA, IUGR, low apgars, low cord gases, hydramnios, etc.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

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


Locations
United States, New York
Mount Sinai Roosevelt Hospital
New York, New York, United States, 10019
Sponsors and Collaborators
St. Luke's-Roosevelt Hospital Center

Responsible Party: St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT02272387     History of Changes
Other Study ID Numbers: 13-0223
First Posted: October 22, 2014    Key Record Dates
Last Update Posted: August 24, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depression, Postpartum
Puerperal Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders
Pregnancy Complications
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents