Is Vitamin D Insufficiency and Deficiency Associated With Antepartum and Postpartum Depression?
| Status: | Terminated |
|---|---|
| Conditions: | Depression, Depression, Women's Studies |
| Therapuetic Areas: | Psychiatry / Psychology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/25/2017 |
| Start Date: | October 2014 |
| End Date: | April 14, 2016 |
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.
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.
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.
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.
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.
We found this trial at
1
site
Click here to add this to my saved trials
