An Evaluation of the Effect of Vitamin D Supplementation on Depressive Symptoms Among Chinese Adolescents

Depressive Symptoms Clinical Trial

Official title:

Effect of Vitamin D Supplementation on Depressive Symptoms in Chinese Adolescents

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06247930
• Other study ID #: 84230079
• Status: Recruiting
• Phase: N/A
• Start date: March 22, 2024
• Est. completion date: December 22, 2024

Study information

• Verified date: March 2024
• Source: Anhui Medical University
• Contact: Puyu Su, PhD
• Phone: 8613856058551
• Email: supuyu[@]ahmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this randomized controlled clinical trial is to investigate the effects of vitamin D3 supplementation on depression in Chinese 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.

Description:

Investigators will conduct a randomized controlled trial to examine whether vitamin D3 supplementation can improve depressive symptoms. A total of 310 participants will be recruited from two middle schools. Inclusion criteria are grades 7th and 8th students whose caregivers signed informed consents, self-reported mild and moderate depressive symptoms with scores of BDI-II>13, and serum 25(OH)D concentration of 12-20 ng/mL. Exclusion criteria are the use of anti-psychotic treatments or interventions in the past 3 months; serious health conditions (e.g., major psychiatric disorders, serious infectious diseases, chronic gastrointestinal diseases, and hepatic or renal diseases); the use of vitamin D supplements in the past 3 months; self-reported suicidal plans/attempts in the past 3 months; intellectual disability. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 310
• Est. completion date: December 22, 2024
• Est. primary completion date: June 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 16 Years

Eligibility

Inclusion Criteria:

1. 7th and 8th grade students;

2. students whose caregivers signed informed consents;

3. students with serum 25(OH)D concentration of 12-20 ng/mL;

4. students with self-reported mild and moderate depressive symptoms (BDI-II score ranged from 13 to 28)

Exclusion Criteria:

1. students who are currently receiving or have used anti-psychotic treatments or interventions (including drugs and non-drugs) in the past 3 months;

2. students who have serious health conditions (e.g., major psychiatric disorders, serious infectious diseases, chronic gastrointestinal diseases, and hepatic or renal diseases);

3. students who are currently taking or have taken vitamin D supplements in the past 3 months;

4. students with self-reported suicidal plans/attempts in the past 3 months;

5. students with intellectual disability.

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms

Intervention

Dietary Supplement:
• 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.
• Vitamin D3 placebo
Three capsules for 6 weeks, followed by one capsule for 6 weeks.

Behavioral:
• Mental health education
The mental health education consists of providing a brochure with information about mental health problems. Additionally, participants will receive a set of 5 educational mental health videos regarding depression. Each of these videos is 15 minutes long.

Locations

Country	Name	City	State
China	Susong County Zhenxing School	Anqing	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
Anhui Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Aggression Scores	Aggression will be assessed by the Buss-Warren Aggression Questionnaire (BWAQ). It consists of 34 items. Each item is answered on a 5-point Likert scale ranging from 1 (not at all like me) to 5 (completely like me), and the total score is calculated. The questionnaire measured five constructs related to aggression: physical aggression, verbal aggression, anger, hostility, and indirect aggression. Data from all time points will be used to determine the mean differences in change in aggression scores over all follow-up by randomized treatment.	Baseline, 12, 24, 36 weeks
Other	Irritability Scores	Irritability will be measured by the Affective Reactivity Index (ARI). The ARI scale contains six symptom items. Respondents rate irritability over the last 3 months. Each item has a three-level response category: 'not true', 'somewhat true', 'certainly true'- scored as '0', '1', '2', respectively, giving a range of possible scores of 0-12. The total scores will be calculated and used in this study. Data from all time points will be used to determine the mean differences in change in irritability scores over all follow-up by randomized treatment.	Baseline, 12, 24, 36 weeks
Primary	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.	From randomization to the end of intervention at 3 months
Secondary	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.	Baseline, 2, 4, 6, 9, 24 and 36 weeks
Secondary	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.	Baseline, 2, 4, 6, 9, 12, 24 and 36 weeks
Secondary	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.	Baseline, 6, 12, 24 and 36 weeks
Secondary	Number of Participants with a Suicidal Ideation Event	Suicidal ideation will be asked by the item 'In the past three/six months, have you ever thought about killing yourself?'. Suicidal ideation will be self-reported in the past 3/6 months, which is consistent with the time interval of the evaluation. Specifically, suicidal ideation over the past three months will be assessed at 12 and 24 weeks and suicidal ideation over the past six months will be evaluated at 48 weeks. The responses will be classified as yes or no.	From randomization to the occurrence of the endpoint or to the end of evaluation at 12, 24 or 36 weeks.
Secondary	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.	Baseline, 2, 4, 6, 9, 12, 24 and 36 weeks
Secondary	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.	Baseline, 6, 12, 24 and 36 weeks
Secondary	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.	Baseline, 2, 4, 6, 9, 12, 24 and 36 weeks
Secondary	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.	Baseline, 6, 12, 24, 36 weeks
Secondary	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.	Baseline, 6, 12, 24, 36 weeks
Secondary	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.	Baseline, 6, 12, 24, 36 weeks
Secondary	Health-related Quality of Life Scores	Health-related Quality of Life (HRQOL) will be measured by the Pediatric Quality of Life Inventory 4.0 (PedsQL 4.0). The PedsQL 4.0 has 23 items, and comprise physical (8 items), emotional (5 items), social (5 items) and school functioning (5 items) subscales. The responses are "never a problem" (scored as 0), "almost never a problem" (scored as 1), "sometimes a problem" (scored as 2), "often a problem" (scored as 3), and "almost always a problem" (scored as 4). Items are reverse-scored and linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3= 25, 4 = 0). Two Summary Scores can be computed (the Psychosocial Health Summary Score and the Physical Health Summary Score), as well as a Total Scale Score. Two summary scores and a total score range from 0 to 100. Higher scores indicate better HRQOL. Data from all time points will be used to determine the mean differences in change in health-related quality of life over all follow-up by randomized treatment.	Baseline, 12, 24, 36 weeks