DepressionNCT02272387
Is Vitamin D Insufficiency and Deficiency Associated With Antepartum and Postpartum Depression?
A study testing Vitamin D3 (Cholecalciferol) in people with Depression and Postpartum Depression, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depression, Postpartum Depression
- What is being tested?
- Vitamin D3 (Cholecalciferol)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 151 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to 14 Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai Roosevelt Hospital
New York, New York, 10019
About this study
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.
Read the 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.
- Conditions
- Depression, Postpartum Depression
- Being tested
- Vitamin D3 (Cholecalciferol), Placebo
- Medical subject headings
- Depression, Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3 (Cholecalciferol)Dietary supplement
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 (cholecalciferol) treatment | Active comparator | 50,000 IU vitamin D3 (cholecalciferol) tablet weekly x 8 weeks plus prenatal vitamin (400 IU vitamin D) Receives: Dietary Supplement: Vitamin D3 (Cholecalciferol) |
| Vitamin D placebo | Placebo comparator | Placebo tablet (appearance same as active vitamin D) plus prenatal vitamin (400IU vitamin D) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antepartum and Postpartum Depressive symptoms
We will be using an Edinburgh Postnatal Depression Scale (EPDS) questionnaire to monitor depressive symptoms.
Measured: 9 months
Secondary outcomes (2)
Maternal morbidities
Composite maternal complications: preeclampsia, GDM, delivery complications, chorioamnionitis, etc.
Measured: Antepartum and Delivery
Fetal morbidities
Composite outcomes: SGA, IUGR, low apgars, low cord gases, hydramnios, etc.
Measured: Antepartum and delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study startOct 2014
- Primary completion14 Apr 2016
- Study completion14 Apr 2016
Why it stopped: Low enrollment and limited research staffing
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's-Roosevelt Hospital Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02272387
- Sponsor's protocol ID
- 13-0223
- Status last verified
- Aug 2017
- First submitted
- 16 Oct 2014
- Last updated
- 24 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Vitamin D Insufficiency and Deficiency Associated With Antepartum and Postpartum Depression?
- ClinicalTrials.gov ID
- NCT02272387
- Acronym / sponsor ID
- 13-0223
- Conditions
- Depression, Postpartum Depression
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment and limited research staffing
- Enrolment
- 151 participants (actual)
- Lead sponsor
- St. Luke's-Roosevelt Hospital CenterUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- 14 Apr 2016 (actual)
- Study completion
- 14 Apr 2016 (actual)
- First posted
- 22 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 (cholecalciferol) treatment | Active comparator | Dietary Supplement: Vitamin D3 (Cholecalciferol)50,000 IU vitamin D3 (cholecalciferol) tablet weekly x 8 weeks plus prenatal vitamin (400 IU vitamin D) |
| Vitamin D placebo | Placebo comparator | Other: PlaceboPlacebo tablet (appearance same as active vitamin D) plus prenatal vitamin (400IU vitamin D) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3 (Cholecalciferol) | Dietary supplement | Vitamin D3 (cholecalciferol) treatment |
| Placebo | Other | Vitamin D placebo |
Primary outcome
Antepartum and Postpartum Depressive symptoms
Time frame: 9 months
We will be using an Edinburgh Postnatal Depression Scale (EPDS) questionnaire to monitor depressive symptoms.
2 secondary outcomes
Maternal morbidities
Time frame: Antepartum and Delivery
Fetal morbidities
Time frame: Antepartum and delivery
Results and safety
The study was stopped early (reason given: Low enrollment and limited research staffing). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 (Cholecalciferol) in people with Depression and Postpartum Depression, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low enrollment and limited research staffing). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antepartum and Postpartum Depressive symptoms (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2017.