Depressive SymptomsNCT06247930
An Evaluation of the Effect of Vitamin D Supplementation on Depressive Symptoms Among Chinese Early Adolescents
A study testing Vitamin D3 and Mental health education in people with Depressive Symptoms, run by Anhui Medical University at 2 sites in China.
Trial summary
The goal of this randomized controlled clinical trial is to investigate the effects of vitamin D3 supplementation on depression in Chinese early adolescents with elevated depressive symptoms and vitamin D deficiency. The main question it aims to answer whether vitamin D3 supplementation can reduce depressive symptoms. Read more about this study
- Who is it for?
- Ages 10 to 15 years
- Conditions the study is for
- Depressive Symptoms
- What is being tested?
- Vitamin D3 and Mental health education
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 406 participants
- Where
- 2 sitesChina
- Study dates
- 19 Mar 2024to 24 Jun 2025
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 7th-9th students whose caregivers signed informed consents;
- students with serum 25(OH)D concentrations below 20 ng/mL;
- students with self-reported depressive symptoms (BDI-II score of 14 or higher)
Who cannot join
- students who are currently receiving or have used anti-psychotic treatments or interventions (including drugs and non-drugs) in the past 3 months;
- students who have serious health conditions (e.g., organic or functional brain diseases, major psychiatric disorders, cardiovascular diseases, serious infectious diseases, chronic gastrointestinal diseases, and hepatic or renal diseases);
- students who are currently taking or have taken vitamin D supplements in the past 3 months;
- students with self-reported serious suicidal ideation, suicidal plans and attempts in the past 3 months;
- students with intellectual disability;
- students who are allergic to vitamin D or soybean oil components.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Susong County Guangfu Middle School
Anqing, Anhui, 246500
Susong County Zhenxing School
Anqing, Anhui, 246500
About this study
Official title: Effect of Vitamin D Supplementation on Depressive Symptoms in Chinese Early Adolescents
The goal of this randomized controlled clinical trial is to investigate the effects of vitamin D3 supplementation on depression in Chinese early adolescents with elevated depressive symptoms and vitamin D deficiency. The main question it aims to answer whether vitamin D3 supplementation can reduce depressive symptoms.
Participants in the intervention group will receive vitamin D3 capsules and mental health education. The control group will receive vitamin D3 placebo and mental health education.
Researchers will compare the change in depressive symptoms from baseline to post-intervention at 12 weeks between the intervention and control groups.
Read the detailed description
Investigators will conduct a randomized controlled trial to examine whether vitamin D3 supplementation can improve depressive symptoms. Participants will be recruited from two middle schools. Participants will be randomly assigned into a supplementation or placebo group. Supplementation arm will receive oral dose 2000 IU vitamin D3 per day for 6 weeks and followed by 800 IU per day for 6 weeks; placebo arm will receive placebo every day for 12 weeks. Both of these two groups will receive additional mental health education. For the first 6 weeks, vitamin D or placebo will be administrated every two weeks. For the next 6 weeks, vitamin D or placebo will be administrated every three weeks. The primary outcome of this study is to compare the change of depressive symptoms between supplementation or placebo group from pre- to post-intervention at 12 weeks.
- Conditions
- Depressive Symptoms
- Being tested
- Vitamin D3, Vitamin D3 placebo, Mental health education
- Keywords
- depressive symptoms, vitamin D
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Dietary supplement
Also called Cholecalciferol
2000 IU per day for 6 weeks (two capsules of 800 IU plus one capsule of 400 IU), followed by 800 IU (one capsule of 800 IU) per day for 6 weeks.
Vitamin D3 placeboDietary supplement
Also called Soybean oil
Three capsules for 6 weeks, followed by one capsule for 6 weeks.
Mental health educationBehavioural
The mental health education consists of providing a brochure and videos containing information about mental health problems.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 + Mental Health Education | Experimental | Vitamin D3: 2000 IU per day for 6 weeks (two capsules of 800 IU plus one capsule of 400 IU), followed by 800 IU (one capsule of 800 IU) per day for 6 weeks.
Mental Health Education: consists of providing a brochure and videos containing information about mental health problems. Receives: Dietary Supplement: Vitamin D3; Behavioral: Mental health education |
| Vitamin D3 placebo + Mental Health Education | Placebo comparator | Vitamin D3 placebo (i.e., soybean oil). Mental Health Education: consists of providing a brochure and videos containing information about mental health problems. Receives: Dietary Supplement: Vitamin D3 placebo; Behavioral: Mental health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depressive symptom scores
Depressive symptoms are evaluated by the Chinese version of Beck Depression Inventory (BDI-II-C). The measured outcome was the total BDI-II-C scores. Each of the 21 items can be scored as 0, 1, 2, or 3 points. The range for the BDI-II-C score is 0-63 points; higher scores indicate worse depressive symptoms. Change in BDI-II-C scores from pre to post-intervention were compared between randomized groups, which was the primary outcome of this study.
Measured: From randomization to the end of intervention at 3 months
Secondary outcomes (10)
Depressive Symptoms Scores
Depressive symptoms are assessed by BDI-II-C. Data from all time points will be used to determine the mean differences in change in depressive symptoms scores over all follow-up by randomized treatment.
Measured: Baseline, 6, 9, 24 and 36 weeks
Patient Health Questionnaire-9 Scores
Patient Health Questionnaire-9 (PHQ-9) is a 9-item instrument for measuring the severity of depression. The PHQ-9 is based on the diagnosis of the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) depressive disorders. Each of the 9 items can be scored from 0 (not at all) to 3 (nearly every day), and the total scores of PHQ-9 can range from 0 to 27. The higher score indicates more depressive symptoms. It can be administrated repeatedly and can reflect improvement or worsening of depression in response to treatment. Data from all time points will be used to determine the mean differences in change in depression scores over all follow-up by randomized treatment.
Measured: Baseline, 6, 9, 12, 24 and 36 weeks
Sleep Quality Scores
Sleep quality is evaluated by the Pittsburgh Sleep Quality Index (PSQI). In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. Data from all time points will be used to determine the mean differences in change in sleep quality scores over all follow-up by randomized treatment.
Measured: Baseline, 6, 12, 24 and 36 weeks
Number of Participants with a Suicidal Ideation Event
Suicidal ideation will be asked by the item 'In the past three months, have you ever thought about killing yourself?'. The responses will be classified as yes or no.
Measured: From randomization to the occurrence of the endpoint or to the end of evaluation at 12, 24 or 36 weeks.
Anxiety Symptoms Scores
Anxiety symptoms will be assessed by the Generalized Anxiety Disorder 7-item scale (GAD-7). GAD-7 has seven items and assess the severity of the severity of generalized anxiety symptoms over the past two weeks. Response options include "not at all", "several days", "more than half the days" and "nearly every day". In scoring the GAD-7, each of seven items scored 0 (not at all), 1 (several days), 2 (more than half the days), and 3 (nearly every day). The total scores are calculated and range from 0 to 21. Higher scores indicate worse anxiety symptoms. Data from all time points will be used to determine the mean differences in change in sleep quality scores over all follow-up by randomized treatment.
Measured: Baseline, 6, 9, 12, 24 and 36 weeks
Psychological Resilience Scores
Resilience will be evaluated by the Connor-Davidson Resilience Scale (CD-RISC). The CD-RISC consists of 25 items, which are evaluated on a five-point Likert scale ranging from 0 to 4: not true at all (0), rarely true (1), sometimes true (2), often true (3), and true nearly all of the time (4) - these ratings result in a number between 0-100, and higher scores indicate higher resilience. Data from all time points will be used to determine the mean differences in change in resilience scores over all follow-up by randomized treatment.
Measured: Baseline, 6, 12 weeks
Hopelessness Scores
Hopelessness will be evaluated by the Beck Hopelessness Scale (BHS). The BHS consists of 20 dichotomous "true/false" items that aims to assess three major aspects of hopelessness (i.e., feelings about the future, loss of motivation, and expectations). Higher total scores indicate greater hopelessness (range 0-20). Data from all time points will be used to determine the mean differences in change in hopelessness scores over all follow-up by randomized treatment.
Measured: Baseline, 6, 12, 24 and 36 weeks
Emotional and Behavioral Problems Scores
Emotional and behavioral problems are assessed by the Pediatric Symptom Checklist-17 (PSC-17). The PSC-17 consists of 17 items, and is categorized as three subscales (5 items on internalizing subscale, 5 items on attention subscale, and 7 items on externalizing subscale). The responses are 0 ("Never"), 1 ("Sometimes") and 2 ("Often"). The total score of the PSC-17 is calculated, and ranges from 0 to 34. Higher scores can indicate an increased likelihood of a behavioral health disorder being present. Data from all time points will be used to determine the mean differences in change in internalizing, attention and externalizing scores over all follow-up by randomized treatment.
Measured: Baseline, 6, 9, 12, 24, 36 weeks
Loneliness Scores
Loneliness will be measured by the short-form University of California, Los Angeles (UCLA) Loneliness Scale (ULS-8). The total score ranges from 8 to 32 points, with higher scores suggesting a higher degree of loneliness. Data from all time points will be used to determine the mean differences in change in loneliness scores over all follow-up by randomized treatment.
Measured: Baseline, 6, 12, 24, 36 weeks
Emotional Regulation Ability Scores
The Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA) is a 10-item scale to measure respondents' tendency to regulate their emotions and the total scores will be used in this study. Items are rated on a 5-point Likert-type response scale (1=strongly disagree, 2=disagree, 3=half and half, 4=agree and 5=strongly agree). The total score ranges from 10 to 50. Higher scores indicate greater use of the emotional regulation strategy. Data from all time points will be used to determine the mean differences in change in emotional regulation scores over all follow-up by randomized treatment.
Measured: Baseline, 6, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start19 Mar 2024
- Primary completion1 Apr 2025
- Study completion24 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies 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, Outcomes assessor
- Enrolment
- 406 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuan Mengyuan, Anhui Medical University
- Investigators
- Puyu Su, Professor, Principal investigator, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06247930
- Sponsor's protocol ID
- 84230079
- Status last verified
- Sep 2024
- First submitted
- 31 Jan 2024
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will be only used in a peer-reviewed journal in order to protect the privacy of the study participants.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin D Supplementation on Depressive Symptoms in Chinese Early Adolescents
- ClinicalTrials.gov ID
- NCT06247930
- Acronym / sponsor ID
- 84230079
- Conditions
- Depressive Symptoms
- Keywords
- depressive symptoms, vitamin D
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 406 participants (actual)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Study start
- 19 Mar 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 24 Jun 2025 (actual)
- First posted
- 8 Feb 2024 (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 goal of this randomized controlled clinical trial is to investigate the effects of vitamin D3 supplementation on depression in Chinese early adolescents with elevated depressive symptoms and vitamin D deficiency. The main question it aims to answer whether vitamin D3 supplementation can reduce depressive symptoms.
Participants in the intervention group will receive vitamin D3 capsules and mental health education. The control group will receive vitamin D3 placebo and mental health education.
Researchers will compare the change in depressive symptoms from baseline to post-intervention at 12 weeks between the intervention and control groups.
Detailed description
Investigators will conduct a randomized controlled trial to examine whether vitamin D3 supplementation can improve depressive symptoms. Participants will be recruited from two middle schools. Participants will be randomly assigned into a supplementation or placebo group. Supplementation arm will receive oral dose 2000 IU vitamin D3 per day for 6 weeks and followed by 800 IU per day for 6 weeks; placebo arm will receive placebo every day for 12 weeks. Both of these two groups will receive additional mental health education. For the first 6 weeks, vitamin D or placebo will be administrated every two weeks. For the next 6 weeks, vitamin D or placebo will be administrated every three weeks. The primary outcome of this study is to compare the change of depressive symptoms between supplementation or placebo group from pre- to post-intervention at 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 + Mental Health Education | Experimental | Dietary Supplement: Vitamin D3, Behavioral: Mental health educationVitamin D3: 2000 IU per day for 6 weeks (two capsules of 800 IU plus one capsule of 400 IU), followed by 800 IU (one capsule of 800 IU) per day for 6 weeks. Mental Health Education: consists of providing a brochure and videos containing information about mental health problems. |
| Vitamin D3 placebo + Mental Health Education | Placebo comparator | Dietary Supplement: Vitamin D3 placebo, Behavioral: Mental health educationVitamin D3 placebo (i.e., soybean oil). Mental Health Education: consists of providing a brochure and videos containing information about mental health problems. |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 7th-9th students whose caregivers signed informed consents;
- students with serum 25(OH)D concentrations below 20 ng/mL;
- students with self-reported depressive symptoms (BDI-II score of 14 or higher)
Key exclusion criteria (6 listed)
- students who are currently receiving or have used anti-psychotic treatments or interventions (including drugs and non-drugs) in the past 3 months;
- students who have serious health conditions (e.g., organic or functional brain diseases, major psychiatric disorders, cardiovascular diseases, serious infectious diseases, chronic gastrointestinal diseases, and hepatic or renal diseases);
- students who are currently taking or have taken vitamin D supplements in the past 3 months;
- students with self-reported serious suicidal ideation, suicidal plans and attempts in the past 3 months;
- students with intellectual disability;
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 D3Also: Cholecalciferol2000 IU per day for 6 weeks (two capsules of 800 IU plus one capsule of 400 IU), followed by 800 IU (one capsule of 800 IU) per day for 6 weeks. | Dietary supplement | Vitamin D3 + Mental Health Education |
| Vitamin D3 placeboAlso: Soybean oilThree capsules for 6 weeks, followed by one capsule for 6 weeks. | Dietary supplement | Vitamin D3 placebo + Mental Health Education |
| Mental health educationThe mental health education consists of providing a brochure and videos containing information about mental health problems. | Behavioural | Vitamin D3 + Mental Health Education, Vitamin D3 placebo + Mental Health Education |
Primary outcome
Change in depressive symptom scores
Time frame: From randomization to the end of intervention at 3 months
Depressive symptoms are evaluated by the Chinese version of Beck Depression Inventory (BDI-II-C). The measured outcome was the total BDI-II-C scores. Each of the 21 items can be scored as 0, 1, 2, or 3 points. The range for the BDI-II-C score is 0-63 points; higher scores indicate worse depressive symptoms. Change in BDI-II-C scores from pre to post-intervention were compared between randomized groups, which was the primary outcome of this study.
10 secondary outcomes
Depressive Symptoms Scores
Time frame: Baseline, 6, 9, 24 and 36 weeks
Patient Health Questionnaire-9 Scores
Time frame: Baseline, 6, 9, 12, 24 and 36 weeks
Sleep Quality Scores
Time frame: Baseline, 6, 12, 24 and 36 weeks
Number of Participants with a Suicidal Ideation Event
Time frame: From randomization to the occurrence of the endpoint or to the end of evaluation at 12, 24 or 36 weeks.
Anxiety Symptoms Scores
Time frame: Baseline, 6, 9, 12, 24 and 36 weeks
Psychological Resilience Scores
Time frame: Baseline, 6, 12 weeks
Hopelessness Scores
Time frame: Baseline, 6, 12, 24 and 36 weeks
Emotional and Behavioral Problems Scores
Time frame: Baseline, 6, 9, 12, 24, 36 weeks
Loneliness Scores
Time frame: Baseline, 6, 12, 24, 36 weeks
Emotional Regulation Ability Scores
Time frame: Baseline, 6, 12 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 2 Jul 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will be only used in a peer-reviewed journal in order to protect the privacy of the study participants.
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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.
Puyu Su, Professor principal investigator
Anhui Medical University
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 and Mental health education in people with Depressive Symptoms, run by Anhui Medical University at 2 sites in China.
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 6 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 2 Jul 2025. 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 China. 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 in depressive symptom scores (time frame: From randomization to the end of intervention at 3 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 2 Jul 2025.