Bipolar DisorderNCT01884844
Vitamin D Supplementation for Bipolar Depression
A study testing Vitamin D3, Cholecalciferol in people with Bipolar Disorder and Bipolar Depression, run by University of Massachusetts, Worcester at 2 sites in United States.
Trial summary
The purpose of this study is to whether vitamin d supplementation in those with low levels may reduce depression symptoms in people experiencing bipolar depression. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bipolar Disorder, Bipolar Depression
- What is being tested?
- Vitamin D3, Cholecalciferol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2013to Aug 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults >18years old
- Bipolar disorder (I,II or NOS),
- MADRS Score>7 (mild),
- 25(OH)D level <30ng/ml (insufficient).
- able to take the prescribed vitamin D by mouth
Who cannot join
- Systemic diseases such as:
- liver and kidney diseases,
- known parathyroid disorder,
- disorders of vitamin D metabolism,
- taking vitamin D replacement therapy,
- fat digestion disorder,
Show all 13Show fewer
- diabetes mellitus,
- gi surgery
- If the serum calcium in the range 2.50-2.55 mmol L, inclusion required a serum PTH below 5.0 pmol L-acute psychiatric urgency:
- active suicidality,
- acute psychosis,
- active substance use<6mo or
- pregnant or nursing females
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Massachusettes
Worcester, Massachusetts, 01604
University of Massachusetts School of Medicine
Worcester, Massachusetts, 01605
About this study
Official title: Randomized Double-Blind Placebo-Controlled Pilot Study of Vitamin D Supplementation for the Treatment of Bipolar Depression
The purpose of this study is to whether vitamin d supplementation in those with low levels may reduce depression symptoms in people experiencing bipolar depression.
- Conditions
- Bipolar Disorder, Bipolar Depression
- Being tested
- Vitamin D3, Cholecalciferol, Placebo
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3, CholecalciferolDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 | Experimental | Vitamin D3, Cholecalciferol, 5000IU po qday for 12 weeks Receives: Drug: Vitamin D3, Cholecalciferol |
| Placebo | Placebo comparator | methylcellulose po qday for 12weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Montgomery-Åsberg Depression Rating Scale
Montgomery-Åsberg Depression Rating Scale Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.
The questionnaire includes questions on the following symptoms 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts
Usual cutoff points are:
0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression.
Measured: baseline and at 12 week completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bipolar DisorderStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wendy Marsh, University of Massachusetts, Worcester
- Investigators
- Wendy Marsh, MD MSc, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01884844
- Sponsor's protocol ID
- NARSADYI13-15
- Status last verified
- May 2018
- First submitted
- 17 Jun 2013
- Last updated
- 19 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-Blind Placebo-Controlled Pilot Study of Vitamin D Supplementation for the Treatment of Bipolar Depression
- ClinicalTrials.gov ID
- NCT01884844
- Acronym / sponsor ID
- NARSADYI13-15
- Conditions
- Bipolar Disorder, Bipolar Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 24 Jun 2013 (estimated)
- Results
- Posted 19 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to whether vitamin d supplementation in those with low levels may reduce depression symptoms in people experiencing bipolar depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 | Experimental | Drug: Vitamin D3, CholecalciferolVitamin D3, Cholecalciferol, 5000IU po qday for 12 weeks |
| Placebo | Placebo comparator | Drug: Placebomethylcellulose po qday for 12weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults >18years old
- Bipolar disorder (I,II or NOS),
- MADRS Score>7 (mild),
- 25(OH)D level <30ng/ml (insufficient).
- able to take the prescribed vitamin D by mouth
Key exclusion criteria (13 listed)
- liver and kidney diseases,
- known parathyroid disorder,
- disorders of vitamin D metabolism,
- taking vitamin D replacement therapy,
- fat digestion disorder,
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 | Drug | Vitamin D3 |
| Placebo | Drug | Placebo |
Primary outcome
Change in Montgomery-Åsberg Depression Rating Scale
Time frame: baseline and at 12 week completion
Montgomery-Åsberg Depression Rating Scale Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The questionnaire includes questions on the following symptoms 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts Usual cutoff points are: 0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Wendy Marsh, MD MSc principal investigator
University of Massachusetts, Worcester
2 sites 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 Bipolar Disorder and Bipolar Depression, run by University of Massachusetts, Worcester at 2 sites 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 5 inclusion and 13 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: finished, as of the sponsor's last update on 19 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 19 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Montgomery-Åsberg Depression Rating Scale (time frame: baseline and at 12 week completion). 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 19 Jun 2018; AzTrials last refreshed its copy on 29 Oct 2026.