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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

Tracking Information
First Submitted Date  ICMJE October 16, 2014
First Posted Date  ICMJE October 22, 2014
Last Update Posted Date August 24, 2017
Actual Study Start Date  ICMJE October 2014
Actual Primary Completion Date April 14, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 20, 2014)
Antepartum and Postpartum Depressive symptoms [ Time Frame: 9 months ]
We will be using an Edinburgh Postnatal Depression Scale (EPDS) questionnaire to monitor depressive symptoms.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2014)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Is Vitamin D Insufficiency and Deficiency Associated With Antepartum and Postpartum Depression?
Official Title  ICMJE Is Vitamin D Insufficiency and Deficiency Associated With Antepartum and Postpartum Depression?
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Depression
  • Postpartum Depression
Intervention  ICMJE
  • Dietary Supplement: Vitamin D3 (Cholecalciferol)
  • Other: Placebo
Study Arms  ICMJE
  • Active Comparator: Vitamin D3 (cholecalciferol) treatment
    50,000 IU vitamin D3 (cholecalciferol) tablet weekly x 8 weeks plus prenatal vitamin (400 IU vitamin D)
    Intervention: Dietary Supplement: Vitamin D3 (Cholecalciferol)
  • Placebo Comparator: Vitamin D placebo
    Placebo tablet (appearance same as active vitamin D) plus prenatal vitamin (400IU vitamin D)
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 23, 2017)
151
Original Estimated Enrollment  ICMJE
 (submitted: October 20, 2014)
750
Actual Study Completion Date  ICMJE April 14, 2016
Actual Primary Completion Date April 14, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02272387
Other Study ID Numbers  ICMJE 13-0223
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party St. Luke's-Roosevelt Hospital Center
Study Sponsor  ICMJE St. Luke's-Roosevelt Hospital Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account St. Luke's-Roosevelt Hospital Center
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP