Bipolar DisorderNCT05357859
Vitamin D for Cognition in Bipolar Disorder
A study testing solubilized vitamin D3 and medium chain triglyceride in people with Bipolar Disorder, run by Taipei City Hospital at 1 site in Taiwan.
Trial summary
Conduct randomized double-blind controlled trial (RCT), to examine the effects of vitamin D on cognitive performance in euthymic BD. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- solubilized vitamin D3 and medium chain triglyceride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 May 2022to 20 Nov 2023
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who diagnosed with BD-I based on the Diagnostic and Statistical Manual (DSM-IV) criteria are consecutively referred by board-certified psychiatrists in Taipei City Hospital, Songde branch.
- Age of participants should range from 20 to 65 years old.
- No history of vitamin D supplementation within three months before the study.
- The BD patients in their euthymic state (both Hamilton Depression Rating Scale and Young Mania Rating Scale ≤ 8) and no change of their psychoactive medications in recent three months.
Who cannot join
- With known substance use disorder (except nicotine use disorder)
- With any disorder with known neurological symptoms or complications (ex. brain injury, stroke or brain lesions)
- Comorbid with schizophrenia spectrum disorders
- With active physical condition (such as renal impairment, hepatic failure…) or pregnancy
- Inability to complete the standard assessment or incapability of providing informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Vitamin D Supplement for Cognitive Function in Patients With Bipolar Disorder- Randomized Double-Blind Controlled Trial
Conduct randomized double-blind controlled trial (RCT), to examine the effects of vitamin D on cognitive performance in euthymic BD.
Read the detailed description
Bipolar disorder (BD) is a chronic mental disease related to recurrent episodes along with cognitive or functional decline. Comparing efficacy of pharmacological interventions targeting to treat cognitive deficit in BD is unexplored. The majority of the observational studies demonstrate a significant association between low serum vitamin D and compromised cognition in a wide range of neuropsychiatry diseases. Recent survey further revealed the high prevalence of hypovitamin D in BD. The effect of supplement and association between vitamin D and cognition in BD and the underlying mechanism is unclear.
The investigators will collect vitamin D levels and assess their association with cognition in a euthymic bipolar cohort (N=200) for screen. Then, the investigators estimate to recruit 120 of participants with cognitive deficits and combined vitamin D deficiency, to conduct a RCT. Participants will keep their usual treatment and will be randomized to receive either vitamin D supplement or a placebo for eight weeks. Cognitive test, adverse side effect, mood status and blood 25(OH)D levels and biomarkers will be measured before and after intervention.
- Conditions
- Bipolar Disorder
- Being tested
- solubilized vitamin D3, medium chain triglyceride
- Keywords
- bipolar disorder, vitamin D, cognition
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
solubilized vitamin D3Dietary supplement
solubilized vitamin D3
medium chain triglycerideDietary supplement
MCT with same amount
| Study group | Role | What they receive |
|---|---|---|
| Intervention: solubilized vitamin D3 in MCT | Experimental | The intervention dose and duration aims to correct their vitamin D deficiency to sufficient status (total serum 25(OH)D >/=30 ng/mL or 75 nmol/L). According to an oral cholecalciferol (D3) loading dose guideline for vitamin D-deficient adults (van Groningen et al. 2010), cumulative dose of more than 200,000 IU solubilized vitamin D3 would be applied in current RCT, with make sure the sufficient supplement. Intervention group will receive 144,000 IU in week0 (W0) and then every 2 weeks of 72,000 IU for total 8 weeks (totally 5 times: 144,000 IU wk0/ 72,000 IU wk2/ 72,000 IU wk4/ 72,000 IU wk6/ 72,000 IU wk8), theoretically to achieve sufficient levels of vitamin D. Receives: Dietary Supplement: solubilized vitamin D3 |
| Placebo: MCT with same amount | Placebo comparator | control group will receive same volume amount of medium chain triglyceride (MCT). Receives: Dietary Supplement: medium chain triglyceride |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of cognition
Change from Baseline Brief Assessment of Cognition in Affective Disorders (BAC-A) score at week 10
Measured: Week 0, Week 10
Secondary outcomes (5)
change of serum vitamin D levels
change from baseline serum vitamin D levels to week 10, unit: ng/mL
Measured: Week 0, Week 10
change of serum creatinine
change from baseline serum creatinine to week 10, unit: mg/dL
Measured: Week 0, Week 10
change of blood albumin
change from baseline blood albumin to week 10, unit: g/dL
Measured: Week 0, Week 10
change of blood parathyroid hormone
change from baseline parathyroid hormone to week 10, unit: pg/mL
Measured: Week 0, Week 10
change of serum calcium levels
change from baseline serum calcium levels to week 10, unit: mg/dL
Measured: Week 0, Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start3 May 2022
- Primary completion17 Nov 2023
- Study completion20 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- double blinded RCT
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Wen Yin Chen, Taipei City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05357859
- Sponsor's protocol ID
- vitamin D in bipolar
- Status last verified
- Nov 2023
- First submitted
- 18 Apr 2022
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: individual patient data can be sharing with de-identification process after asking
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin D Supplement for Cognitive Function in Patients With Bipolar Disorder- Randomized Double-Blind Controlled Trial
- ClinicalTrials.gov ID
- NCT05357859
- Acronym / sponsor ID
- vitamin D in bipolar
- Conditions
- Bipolar Disorder
- Keywords
- bipolar disorder, vitamin D, cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Taipei City HospitalOther government
- Study start
- 3 May 2022 (actual)
- Primary completion
- 17 Nov 2023 (actual)
- Study completion
- 20 Nov 2023 (actual)
- First posted
- 3 May 2022 (actual)
- 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.
Conduct randomized double-blind controlled trial (RCT), to examine the effects of vitamin D on cognitive performance in euthymic BD.
Detailed description
Bipolar disorder (BD) is a chronic mental disease related to recurrent episodes along with cognitive or functional decline. Comparing efficacy of pharmacological interventions targeting to treat cognitive deficit in BD is unexplored. The majority of the observational studies demonstrate a significant association between low serum vitamin D and compromised cognition in a wide range of neuropsychiatry diseases. Recent survey further revealed the high prevalence of hypovitamin D in BD. The effect of supplement and association between vitamin D and cognition in BD and the underlying mechanism is unclear.
The investigators will collect vitamin D levels and assess their association with cognition in a euthymic bipolar cohort (N=200) for screen. Then, the investigators estimate to recruit 120 of participants with cognitive deficits and combined vitamin D deficiency, to conduct a RCT. Participants will keep their usual treatment and will be randomized to receive either vitamin D supplement or a placebo for eight weeks. Cognitive test, adverse side effect, mood status and blood 25(OH)D levels and biomarkers will be measured before and after intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- double blinded RCT
| Arm | Type | Receives |
|---|---|---|
| Intervention: solubilized vitamin D3 in MCT | Experimental | Dietary Supplement: solubilized vitamin D3The intervention dose and duration aims to correct their vitamin D deficiency to sufficient status (total serum 25(OH)D >/=30 ng/mL or 75 nmol/L). According to an oral cholecalciferol (D3) loading dose guideline for vitamin D-deficient adults (van Groningen et al. 2010), cumulative dose of more than 200,000 IU solubilized vitamin D3 would be applied in current RCT, with make sure the sufficient supplement. Intervention group will receive 144,000 IU in week0 (W0) and then every 2 weeks of 72,000 IU for total 8 weeks (totally 5 times: 144,000 IU wk0/ 72,000 IU wk2/ 72,000 IU wk4/ 72,000 IU wk6/ 72,000 IU wk8), theoretically to achieve sufficient levels of vitamin D. |
| Placebo: MCT with same amount | Placebo comparator | Dietary Supplement: medium chain triglyceridecontrol group will receive same volume amount of medium chain triglyceride (MCT). |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who diagnosed with BD-I based on the Diagnostic and Statistical Manual (DSM-IV) criteria are consecutively referred by board-certified psychiatrists in Taipei City Hospital, Songde branch.
- Age of participants should range from 20 to 65 years old.
- No history of vitamin D supplementation within three months before the study.
- The BD patients in their euthymic state (both Hamilton Depression Rating Scale and Young Mania Rating Scale ≤ 8) and no change of their psychoactive medications in recent three months.
Key exclusion criteria (5 listed)
- With known substance use disorder (except nicotine use disorder)
- With any disorder with known neurological symptoms or complications (ex. brain injury, stroke or brain lesions)
- Comorbid with schizophrenia spectrum disorders
- With active physical condition (such as renal impairment, hepatic failure…) or pregnancy
- Inability to complete the standard assessment or incapability of providing informed consent
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 |
|---|---|---|
| solubilized vitamin D3solubilized vitamin D3 | Dietary supplement | Intervention: solubilized vitamin D3 in MCT |
| medium chain triglycerideMCT with same amount | Dietary supplement | Placebo: MCT with same amount |
Primary outcome
change of cognition
Time frame: Week 0, Week 10
Change from Baseline Brief Assessment of Cognition in Affective Disorders (BAC-A) score at week 10
5 secondary outcomes
change of serum vitamin D levels
Time frame: Week 0, Week 10
change of serum creatinine
Time frame: Week 0, Week 10
change of blood albumin
Time frame: Week 0, Week 10
change of blood parathyroid hormone
Time frame: Week 0, Week 10
change of serum calcium levels
Time frame: Week 0, Week 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: No. individual patient data can be sharing with de-identification process after asking
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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 solubilized vitamin D3 and medium chain triglyceride in people with Bipolar Disorder, run by Taipei City Hospital at 1 site in Taiwan.
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 4 inclusion and 5 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 22 Nov 2023. 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 Taiwan. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 of cognition (time frame: Week 0, Week 10). 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 22 Nov 2023.