Major DepressionNCT04898725
Effects of Vitamin D Supplementation on Depression and Inflammatory Markers
A study testing Vitamin D3 in people with Major Depression and Vitamin D Deficiency, run by Mackay Memorial Hospital at 1 site in Taiwan.
Trial summary
The current study is designed as a prospective partially randomized patient preference (PRPP) trial and recruit psychiatric outpatients or inpatients. Participants who agree to receive randomization will be randomly assigned into a supplementation or placebo group, after stratification for pre-intervention vitamin D… Read more about this study
- Who is it for?
- Ages 10 to 24 years
- Conditions the study is for
- Major Depression, Vitamin D Deficiency
- What is being tested?
- Vitamin D3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Dec 2020to 31 Jul 2024
- 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 10 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 1.patients who attend psychiatric outpatient clinics or who are admitted to the psychiatric inpatient ward at the above sites.
- 2.clinical diagnosis of depression-related disorders and scores of HDRS-17 ≥ 10.
- 3.psychotropics have been kept unchanged for at least a month.
- 4.aged 10 to 24.
- 5.serum 25-hydroxycholecalciferol (25-OH-D) levels lower than 20 ng/ml.
Who cannot join
- 1.endocrine disorders
- including diabetes
- thyroid
- parathyroid disorder.
- 2.serious neurological disorders
- epilepsy
Show all 29Show fewer
- severe traumatic brain injury
- neurodegenerative conditions
- 3.liver disease
- 4.kidney disease
- 5.heart disease
- 6.other serious health conditions.
- 7.severe mental disorders
- Organic mental disorders
- Alcohol or substance use disorders active within 3 months
- Schizophrenia
- Delusional disorder
- Psychotic disorders not elsewhere classified.
- Bipolar disorder.
- Autistic spectrum disorder.
- Anorexia nervosa.
- Mental retardation with IQ less than 70.
- High violence or suicide risk.
- 8.Patients use drugs or herbals interfering with vitamin D metabolisms
- phenobarbital
- phenytoin
- anti-tuberculosis drugs
- thiazide diuretics.
- 9.Pregnant or expect to be pregnant during study participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Vitamin D Supplementation on Depression and Inflammatory Markers in Adolescent and Youth With Major Depression and Vitamin D-deficiency: a Partially Randomized Preference Trial in Taiwan
The current study is designed as a prospective partially randomized patient preference (PRPP) trial and recruit psychiatric outpatients or inpatients. Participants who agree to receive randomization will be randomly assigned into a supplementation or placebo group, after stratification for pre-intervention vitamin D status (12-20 ng/mL or <12 ng/mL) and depression status (HDRS-17 ≥ 17 or < 17). Participants who decline randomization but agree to receive follow-up in the observational cohort choose their preferred method (either 4800 IU vitamin D3 per day, or usual care without supplementation). Severity of depression, any change of medication, and side effect will be assessed at baseline and at 2-week intervals for 8 weeks. Serum levels of 25(OH)D, C-Reactive protein (CRP) and 12 cytokines, anthropometrical measurements, dietary intake, physical activity and sun exposure will be assessed at baseline and post-intervention. Additionally, serum levels of 25(OH)D will be assessed at 4 weeks to ensure its safety level.
Read the detailed description
Investigators will conduct a partially randomized patient preference (PRPP) trial and recruit psychiatric outpatients or inpatients. Inclusion criteria are young people aged 10 to 24, fulfilling the DSM-V criteria of major depressive disorder (MDD) with scores of HDRS-17≥10, psychotropic medication have been kept unchanged for a month and will remain unchanged during intervention period, and serum 25-hydroxycholecalciferol (25-OH-D) levels lower than 20 ng/ml. Exclusion criteria are comorbid with organic mental disorders, alcohol or substance use disorders, schizophrenia, delusion disorder, bipolar disorder, autistic spectrum disorder, anorexia nervosa, and IQ less than 70; endocrine disorders including diabetes, thyroid and parathyroid disorder; serious neurological disorders including epilepsy, severe traumatic brain injury, and neurodegenerative conditions; liver disease, kidney disease, heart disease or other serious health conditions; use drug interfering with vitamin D metabolism.
Participants who agree to receive randomization will be randomly assigned into a supplementation or placebo group, after stratification for pre-intervention vitamin D status (12-20 ng/mL or <12 ng/mL) and depression status (HDRS-17 ≥ 17 or < 17). Supplementation arm will receive oral dose 4800 IU vitamin D3 per day (three soft capsules of 800 IU vitamin D, twice a day) and placebo arm will receive placebo every day (three soft capsules with identical appearance, twice a day) for 8 weeks. Both groups continue to receive standard psychiatric care by child psychiatrists. Randomization and allocation will be concealed from researchers, participants and treating physicians. Participants who decline randomization but agree to receive follow-up in the observational cohort choose their preferred method (either 4800 IU vitamin D3 per day, or usual care without supplementation). Severity of depression, any change of medication, and side effect will be assessed at baseline and at 2-week intervals for 8 weeks. Serum levels of 25(OH)D, CRP and 12 cytokines, anthropometrical measurements, dietary intake, physical activity and sun exposure will be assessed at baseline and post-intervention. Additionally, serum levels of 25(OH)D will be assessed at 4 weeks to ensure its safety level.
- Conditions
- Major Depression, Vitamin D Deficiency
- Being tested
- Vitamin D3
- Medical subject headings
- Depressive Disorder, Major, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Dietary supplement
Vitamin D3 4800IU daily
| Study group | Role | What they receive |
|---|---|---|
| Vit D Group (randomized) | Experimental | Subjects will be randomly assigned to receive a daily vitamin D supplementation (4800IU daily) for 8 weeks Receives: Dietary Supplement: Vitamin D3 |
| Control Group (randomized) | No intervention | Subjects will be randomly assigned to receive a placebo for 8 weeks. |
| Preference Vit D Group (non-randomized) | Experimental | Subjects with a strong preference to receive a daily vitamin D supplementation (4800IU daily) for 8 weeks. Receives: Dietary Supplement: Vitamin D3 |
| Preference no Vit D Group (non-randomized) | No intervention | Subjects with a strong preference to receive usual care (not receiving vitamin D supplements) for 8 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of total score of 17-item Hamilton Depression Rating Scale (HDRS-17)
17-item Hamilton Depression Rating Scale is an interview-based instrument for rating the overall levels of severity of the symptoms of depression and the response to treatment. Each item is rated from 0 to 4 or 0 to 2; the scores correspond to increases in severity. Total scores range from 0 to 52.
Measured: baseline and at 8 weeks (the end of intervention)
Secondary outcomes (6)
17-item Hamilton Depression Rating Scale (HDRS-17)
HDRS-17 is measured totally 5 times, at week 0, 2 weeks, 4 weeks, 6 weeks, 8 weeks. The change in total HDRS-17 score between baseline and the intermediate 2-week, 4-week, 6-week follow-ups were considered secondary outcomes measures.
Measured: change from baseline score at 8 weeks
Response rate of 17-item Hamilton Depression Rating Scale (HDRS-17)
Response rate is defined as a reduction in HDRS-17 total score of at least 50 percent relative to the beginning of the randomized phase (baseline).
Measured: at 2 weeks, 4 weeks, 6 weeks, 8 weeks
Remission rate of 17-item Hamilton Depression Rating Scale (HDRS-17)
Remission rate is defined as an absolute HDRS-17 total score of ≤ 7 at each follow-up assessment.
Measured: at week 2, 4, 6, 8 weeks
End of intervention remission rate in17-item Hamilton Depression Rating Scale (HDRS-17)
Remission rate is defined as an absolute HDRS-17 total score of ≤ 7 at the end of treatment (8 week after intervention).
Measured: at 8 weeks
Change of total score of Beck Depression Inventory-Second Edition
Beck Depression Inventory is a 21-item self-report measure, scored from 0 to 3 (range 0-63), and greater scores indicate severe depression symptoms.Beck Depression Inventory (BDI) is measured totally 5 times, at week 0, 2 weeks, 4 weeks, 6 weeks, 8 weeks. The change in total BDI score between baseline and each of follow-ups (2-week, 4-week, 6-week, 8-week follow-ups) were considered secondary outcomes measures.
Measured: change from baseline score at 8 weeks
Significant change (mean±SD) in vitamin D status
serum levels of 25(OH)D, units of measure is ng/mL
Measured: baseline and at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start25 Dec 2020
- Primary completion2 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shen-Ing,Liu, Mackay Memorial Hospital
- Investigators
- Shen-Ing Liu, PhD, Principal investigator, Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04898725
- Sponsor's protocol ID
- 109-2314-B-195 -017 -MY3
- Status last verified
- Aug 2024
- First submitted
- 4 May 2021
- Last updated
- 9 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vitamin D Supplementation on Depression and Inflammatory Markers in Adolescent and Youth With Major Depression and Vitamin D-deficiency: a Partially Randomized Preference Trial in Taiwan
- ClinicalTrials.gov ID
- NCT04898725
- Acronym / sponsor ID
- 109-2314-B-195 -017 -MY3
- Conditions
- Major Depression, Vitamin D Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- 25 Dec 2020 (actual)
- Primary completion
- 2 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 24 May 2021 (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.
The current study is designed as a prospective partially randomized patient preference (PRPP) trial and recruit psychiatric outpatients or inpatients. Participants who agree to receive randomization will be randomly assigned into a supplementation or placebo group, after stratification for pre-intervention vitamin D status (12-20 ng/mL or <12 ng/mL) and depression status (HDRS-17 ≥ 17 or < 17). Participants who decline randomization but agree to receive follow-up in the observational cohort choose their preferred method (either 4800 IU vitamin D3 per day, or usual care without supplementation). Severity of depression, any change of medication, and side effect will be assessed at baseline and at 2-week intervals for 8 weeks. Serum levels of 25(OH)D, C-Reactive protein (CRP) and 12 cytokines, anthropometrical measurements, dietary intake, physical activity and sun exposure will be assessed at baseline and post-intervention. Additionally, serum levels of 25(OH)D will be assessed at 4 weeks to ensure its safety level.
Detailed description
Investigators will conduct a partially randomized patient preference (PRPP) trial and recruit psychiatric outpatients or inpatients. Inclusion criteria are young people aged 10 to 24, fulfilling the DSM-V criteria of major depressive disorder (MDD) with scores of HDRS-17≥10, psychotropic medication have been kept unchanged for a month and will remain unchanged during intervention period, and serum 25-hydroxycholecalciferol (25-OH-D) levels lower than 20 ng/ml. Exclusion criteria are comorbid with organic mental disorders, alcohol or substance use disorders, schizophrenia, delusion disorder, bipolar disorder, autistic spectrum disorder, anorexia nervosa, and IQ less than 70; endocrine disorders including diabetes, thyroid and parathyroid disorder; serious neurological disorders including epilepsy, severe traumatic brain injury, and neurodegenerative conditions; liver disease, kidney disease, heart disease or other serious health conditions; use drug interfering with vitamin D metabolism.
Participants who agree to receive randomization will be randomly assigned into a supplementation or placebo group, after stratification for pre-intervention vitamin D status (12-20 ng/mL or <12 ng/mL) and depression status (HDRS-17 ≥ 17 or < 17). Supplementation arm will receive oral dose 4800 IU vitamin D3 per day (three soft capsules of 800 IU vitamin D, twice a day) and placebo arm will receive placebo every day (three soft capsules with identical appearance, twice a day) for 8 weeks. Both groups continue to receive standard psychiatric care by child psychiatrists. Randomization and allocation will be concealed from researchers, participants and treating physicians. Participants who decline randomization but agree to receive follow-up in the observational cohort choose their preferred method (either 4800 IU vitamin D3 per day, or usual care without supplementation). Severity of depression, any change of medication, and side effect will be assessed at baseline and at 2-week intervals for 8 weeks. Serum levels of 25(OH)D, CRP and 12 cytokines, anthropometrical measurements, dietary intake, physical activity and sun exposure will be assessed at baseline and post-intervention. Additionally, serum levels of 25(OH)D will be assessed at 4 weeks to ensure its safety level.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vit D Group (randomized) | Experimental | Dietary Supplement: Vitamin D3Subjects will be randomly assigned to receive a daily vitamin D supplementation (4800IU daily) for 8 weeks |
| Control Group (randomized) | No intervention | –Subjects will be randomly assigned to receive a placebo for 8 weeks. |
| Preference Vit D Group (non-randomized) | Experimental | Dietary Supplement: Vitamin D3Subjects with a strong preference to receive a daily vitamin D supplementation (4800IU daily) for 8 weeks. |
| Preference no Vit D Group (non-randomized) | No intervention | –Subjects with a strong preference to receive usual care (not receiving vitamin D supplements) for 8 weeks. |
Who may qualify
- Ages
- 10 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 1.patients who attend psychiatric outpatient clinics or who are admitted to the psychiatric inpatient ward at the above sites.
- 2.clinical diagnosis of depression-related disorders and scores of HDRS-17 ≥ 10.
- 3.psychotropics have been kept unchanged for at least a month.
- 4.aged 10 to 24.
- 5.serum 25-hydroxycholecalciferol (25-OH-D) levels lower than 20 ng/ml.
Key exclusion criteria (29 listed)
- 1.endocrine disorders
- 2.serious neurological disorders
- 3.liver disease
- 4.kidney disease
- 5.heart disease
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 D3Vitamin D3 4800IU daily | Dietary supplement | Preference Vit D Group (non-randomized), Vit D Group (randomized) |
Primary outcome
Change of total score of 17-item Hamilton Depression Rating Scale (HDRS-17)
Time frame: baseline and at 8 weeks (the end of intervention)
17-item Hamilton Depression Rating Scale is an interview-based instrument for rating the overall levels of severity of the symptoms of depression and the response to treatment. Each item is rated from 0 to 4 or 0 to 2; the scores correspond to increases in severity. Total scores range from 0 to 52.
6 secondary outcomes
17-item Hamilton Depression Rating Scale (HDRS-17)
Time frame: change from baseline score at 8 weeks
Response rate of 17-item Hamilton Depression Rating Scale (HDRS-17)
Time frame: at 2 weeks, 4 weeks, 6 weeks, 8 weeks
Remission rate of 17-item Hamilton Depression Rating Scale (HDRS-17)
Time frame: at week 2, 4, 6, 8 weeks
End of intervention remission rate in17-item Hamilton Depression Rating Scale (HDRS-17)
Time frame: at 8 weeks
Change of total score of Beck Depression Inventory-Second Edition
Time frame: change from baseline score at 8 weeks
Significant change (mean±SD) in vitamin D status
Time frame: baseline and at 8 weeks
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 9 Aug 2024.
- 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.
Shen-Ing Liu, PhD principal investigator
Mackay Memorial Hospital
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 in people with Major Depression and Vitamin D Deficiency, run by Mackay Memorial 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 5 inclusion and 29 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 9 Aug 2024. 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. 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 total score of 17-item Hamilton Depression Rating Scale (HDRS-17) (time frame: baseline and at 8 weeks (the end of intervention)). 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 9 Aug 2024.