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

NCT02272387 | Terminated

• 1 other identifier: 13-0223
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Postpartum Depression

Outcome Measures

Primary Outcomes (1)

• Antepartum and Postpartum Depressive symptoms

  We will be using an Edinburgh Postnatal Depression Scale (EPDS) questionnaire to monitor depressive symptoms.

  9 months

Secondary Outcomes (2)

• Maternal morbidities

  Antepartum and Delivery

• Fetal morbidities

  Antepartum and delivery

Study Arms (2)

Vitamin D3 (cholecalciferol) treatment

ACTIVE COMPARATOR

50,000 IU vitamin D3 (cholecalciferol) tablet weekly x 8 weeks plus prenatal vitamin (400 IU vitamin D)

Dietary Supplement: Vitamin D3 (Cholecalciferol)

Vitamin D placebo

PLACEBO COMPARATOR

Placebo tablet (appearance same as active vitamin D) plus prenatal vitamin (400IU vitamin D)

Other: Placebo

Interventions

Vitamin D3 (Cholecalciferol) DIETARY_SUPPLEMENT

Vitamin D3 (cholecalciferol) treatment

Placebo OTHER

Vitamin D placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Luke's-Roosevelt Hospital Center: lead

Study Sites (1)

Mount Sinai Roosevelt Hospital

New York, New York, 10019, United States

Location

MeSH Terms

Conditions

Depression; Depression, Postpartum

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2014
• First Posted: October 22, 2014
• Study Start: October 1, 2014
• Primary Completion: April 14, 2016
• Study Completion: April 14, 2016
• Last Updated: August 24, 2017

Record last verified: 2017-08

Locations

US (1)