An interventional study of Cholecalciferol in Functional Dyspepsia, sponsored by Universitas Sebelas Maret Hospital. Completed at 1 site in Indonesia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Universitas Sebelas Maret Hospital · Not applicable, Interventional, and Treatment
This single-arm study examined whether a 30-day course of oral vitamin D3 (colecalciferol 5,000 IU daily) in adults with functional dyspepsia is accompanied by changes in perceived stress, anxiety, dyspepsia-related quality of life, short-term heart rate variability and blood-count inflammatory indices. It also examined how psychological distress and heart rate variability relate to dyspepsia burden before supplementation.
Background: Psychological distress and autonomic imbalance are thought to contribute to functional dyspepsia (FD), a disorder of gut-brain interaction, and low vitamin D status has been linked to both FD and mood disorders.
Design: Single-center, single-arm, open-label pretest-posttest interventional study at Universitas Sebelas Maret Hospital, Sukoharjo, Central Java, Indonesia. Adult outpatients fulfilling the Rome IV criteria for FD received oral colecalciferol (vitamin D3) 5,000 IU (125 micrograms) once daily for 30 days.
Assessments at baseline and day 30: Nepean Dyspepsia Index (Indonesian version), Perceived Stress Scale-10, State-Trait Anxiety Inventory, short-term heart rate variability (Medicore HRV analysis system: SDNN, RMSSD, total power, LF/HF ratio, physical stress index, ANS balance and ANS activity) and a complete blood count (neutrophil-to-lymphocyte ratio, platelet-to-lymphocyte ratio, red cell distribution width). The Dyspepsia Score and the Hospital Anxiety and Depression Scale were assessed at baseline. Serum 25-hydroxyvitamin D was not measured.
Analysis: Pretest and posttest values were compared with the paired t-test or the Wilcoxon signed-rank test; baseline associations were examined with Pearson, Spearman or eta coefficients. Analyses are exploratory, without adjustment for multiple comparisons.
This record was registered retrospectively, after completion of the study.
7,201 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
This study's enrollment of 25 is below the median of 80 across 6,057 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Universitas Sebelas Maret Hospital is the lead sponsor of 2 studies on the registry; none are open to participants now.
Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Oral colecalciferol (vitamin D3) 5,000 IU (125 micrograms) once daily for 30 days.
Dietary Supplement: Cholecalciferol
Colecalciferol (vitamin D3) 5,000 IU (125 micrograms) taken orally once daily for 30 days, started after baseline assessment.
Also known as: Vitamin D3, Colecalciferol
Change From Baseline in Nepean Dyspepsia Index (NDI) Total Score at 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.
Time frame: Baseline (Day 0) and Day 30
Change From Baseline in Perceived Stress Scale-10 (PSS-10) Total Score at 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.
Time frame: Baseline (Day 0) and Day 30
Change From Baseline in State-Trait Anxiety Inventory State Anxiety (STAI-S) Score at 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.
Time frame: Baseline (Day 0) and Day 30
Change From Baseline in State-Trait Anxiety Inventory Trait Anxiety (STAI-T) Score at 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.
Time frame: Baseline (Day 0) and Day 30
Change From Baseline in Standard Deviation of Normal-to-Normal Intervals (SDNN) at 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).
Time frame: Baseline (Day 0) and Day 30
Change From Baseline in Root Mean Square of Successive Differences (RMSSD) at 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).
Time frame: Baseline (Day 0) and Day 30
Change From Baseline in Heart Rate Variability Total Power at 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).
Time frame: Baseline (Day 0) and Day 30
Change From Baseline in Low-Frequency/High-Frequency (LF/HF) Power Ratio at 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).
Time frame: Baseline (Day 0) and Day 30
Change From Baseline in Physical Stress Index (PSI) at 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).
Time frame: Baseline (Day 0) and Day 30
Change From Baseline in Autonomic Nervous System (ANS) Balance Index at 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).
Time frame: Baseline (Day 0) and Day 30
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2026 to primary completion in Oct 2026, 3 months.
Of 3,836 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's 3 months is below that.
Counting every sponsor, half of 3,938 studies reached it within 12 months; a quarter within 5 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Cholecalciferol
Universitas Sebelas Maret Hospital