Vitamin D3 for Psychological Distress, Dyspepsia Burden and Heart Rate Variability in Functional Dyspepsia
NCT07922473, Not applicable, Completed, Universitas Sebelas Maret Hospital
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Vitamin D3 for Psychological Distress, Dyspepsia Burden and Heart Rate Variability in Functional Dyspepsia | ClinicalTrials.gov |
| NCT number | NCT07922473 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 25 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Universitas Sebelas Maret Hospital | ClinicalTrials.gov |
| Conditions | Functional Dyspepsia | ClinicalTrials.gov |
| Interventions | Cholecalciferol | ClinicalTrials.gov |
| First posted | 2026-11-06 | ClinicalTrials.gov |
| Last updated | 2026-11-06 | ClinicalTrials.gov |
Registered outcomes 10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change From Baseline in Nepean Dyspepsia Index (NDI) Total Score at Day 30 | Baseline (Day 0) and Day 30 | Dyspepsia-related quality of life measured with the validated Indonesian version of the Nepean Dyspepsia Index (NDI), a self-administered questionnaire. Each of the 5 domains (tension/anxiety, interference with daily activities, eating/drinking, knowledge/control, work/study) is scored as the mean of its items, and the total score is the sum of the 5 domain scores. Minimum total score \[\[ISI: nilai minimum\]\], maximum total score \[\[ISI: nilai maksimum\]\]; higher scores indicate a worse outcome (greater dyspepsia-related impairment). Change is calculated as the Day 30 score minus the baseline score. Unit of measure: score on a scale. | ClinicalTrials.gov |
| Primary | Change From Baseline in Perceived Stress Scale-10 (PSS-10) Total Score at Day 30 | Baseline (Day 0) and Day 30 | Perceived stress measured with the 10-item self-report Perceived Stress Scale (PSS-10), Indonesian version. Each item is scored 0 to 4; the total score ranges from 0 (minimum) to 40 (maximum), and higher scores indicate a worse outcome (greater perceived stress). Change is calculated as the Day 30 score minus the baseline score. Unit of measure: score on a scale. | ClinicalTrials.gov |
| Primary | Change From Baseline in State-Trait Anxiety Inventory State Anxiety (STAI-S) Score at Day 30 | Baseline (Day 0) and Day 30 | State anxiety measured with the 20-item state form of the State-Trait Anxiety Inventory (STAI-S). Each item is scored 1 to 4; the total score ranges from 20 (minimum) to 80 (maximum), and higher scores indicate a worse outcome (greater state anxiety). Change is calculated as the Day 30 score minus the baseline score. Unit of measure: score on a scale. | ClinicalTrials.gov |
| Primary | Change From Baseline in State-Trait Anxiety Inventory Trait Anxiety (STAI-T) Score at Day 30 | Baseline (Day 0) and Day 30 | Trait anxiety measured with the 20-item trait form of the State-Trait Anxiety Inventory (STAI-T). Each item is scored 1 to 4; the total score ranges from 20 (minimum) to 80 (maximum), and higher scores indicate a worse outcome (greater trait anxiety). Change is calculated as the Day 30 score minus the baseline score. Unit of measure: score on a scale. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Standard Deviation of Normal-to-Normal Intervals (SDNN) at Day 30 | Baseline (Day 0) and Day 30 | Time-domain heart rate variability index obtained from a resting short-term recording with the Medicore HRV analysis system (Medicore Co., Ltd., Korea) according to the manufacturer's standard protocol. Higher values indicate greater overall heart rate variability. Change is calculated as the Day 30 value minus the baseline value. Unit of measure: milliseconds (ms). | ClinicalTrials.gov |
| Secondary | Change From Baseline in Root Mean Square of Successive Differences (RMSSD) at Day 30 | Baseline (Day 0) and Day 30 | Time-domain heart rate variability index reflecting vagal modulation, obtained from the same resting short-term recording with the Medicore HRV analysis system. Higher values indicate greater vagal modulation. Change is calculated as the Day 30 value minus the baseline value. Unit of measure: milliseconds (ms). | ClinicalTrials.gov |
| Secondary | Change From Baseline in Heart Rate Variability Total Power at Day 30 | Baseline (Day 0) and Day 30 | Frequency-domain heart rate variability index (total spectral power) obtained from the same resting short-term recording with the Medicore HRV analysis system. Higher values indicate greater overall heart rate variability. Change is calculated as the Day 30 value minus the baseline value. Unit of measure: milliseconds squared (ms\^2). | ClinicalTrials.gov |
| Secondary | Change From Baseline in Low-Frequency/High-Frequency (LF/HF) Power Ratio at Day 30 | Baseline (Day 0) and Day 30 | Ratio of low-frequency (0.04-0.15 Hz) to high-frequency (0.15-0.40 Hz) spectral power obtained from the same resting short-term recording with the Medicore HRV analysis system. Higher values indicate relative sympathetic predominance. Change is calculated as the Day 30 value minus the baseline value. Unit of measure: ratio (unitless). | ClinicalTrials.gov |
| Secondary | Change From Baseline in Physical Stress Index (PSI) at Day 30 | Baseline (Day 0) and Day 30 | Device-derived index of physical stress calculated by the Medicore HRV analysis system from the same resting short-term recording, as defined in the manufacturer's clinical manual. Higher values indicate greater physical stress. Change is calculated as the Day 30 value minus the baseline value. Unit of measure: index value (arbitrary units). | ClinicalTrials.gov |
| Secondary | Change From Baseline in Autonomic Nervous System (ANS) Balance Index at Day 30 | Baseline (Day 0) and Day 30 | Device-derived composite index of sympathovagal balance calculated by the Medicore HRV analysis system from the same resting short-term recording, as defined in the manufacturer's clinical manual. Change is calculated as the Day 30 value minus the baseline value. Unit of measure: index value (arbitrary units). | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)