Irritable Bowel SyndromePhase 1NCT02579902
Effect of Vitamin D3 Supplementation in Treatment of Irritable Bowel Syndrome
A Phase 1 study testing Vitamin D3 (Cholecalciferol) in people with Irritable Bowel Syndrome, run by Ahvaz Jundishapur University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to determine whether vitamin D3 supplementation is effective in the treatment of clinical signs, biomarkers of inflammation and oxidative stress due to Irritable Bowel Syndrome (IBS). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Vitamin D3 (Cholecalciferol)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteIran
- Study dates
- Feb 2015to Sep 2015
- Phase
- Phase 1
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients who are diagnosed with Irritable Bowel Syndrome (IBS) according to ROME III criteria; Signed consent by the patient.
Who cannot join
- Patients who have celiac disease (diagnosed by a duodenal biopsy or celiac serological tests)
- Any other diseases of the gastrointestinal tract such as Inflammatory Bowel Disease (IBD)
- Any kind of abdominal surgery
- Chronic disease such as diabetes
- Cardiovascular, hepatic
- Kidney and severe infection
Show all 13Show fewer
- Pregnancy
- Breastfeeding
- Smoking
- Alcohol consumption
- Use of dietary supplements
- Use of vitamin D and calcium supplement during the last year before the study
- Use any medication for signs improvement during the study period.
Trial locations and contacts
1 site in 1 country.
Iran1 site
Ahvaz Jundishapur University of Medical Sciences
Ahvāz, Khuzestan, 15794 - 61357
About this study
Official title: Effect of Vitamin D3 Supplementation on Clinical Signs, Oxidative Stress and Inflammatory Biomarkers in Patients With Irritable Bowel Syndrome
The purpose of this study is to determine whether vitamin D3 supplementation is effective in the treatment of clinical signs, biomarkers of inflammation and oxidative stress due to Irritable Bowel Syndrome (IBS).
Read the detailed description
This randomized double blind clinical trial will be performed on 90 patients (45 in intervention and 45 in control group) diagnosed with IBS. The intervention group will receive 50000 IU vitamin D3 and the control group will receive placebo contains edible paraffin once every 2 weeks for six months. Variables including biomarkers of inflammation and oxidative stress, serum levels of calcium and vitamin D, anthropometric indicators and blood pressure will be measured at baseline and end of the study. The investigators will use Rome III questionnaire for evaluating the clinical signs of the disease. The questionnaires will be filled out at baseline and every 2 weeks by the patients for six months.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Vitamin D3 (Cholecalciferol), placebo
- Keywords
- Irritable Bowel Syndrome, inflammation, oxidative stress, clinical signs, vitamin D3
- Medical subject headings
- Irritable Bowel Syndrome, Inflammation, Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3 (Cholecalciferol)Dietary supplement
50000 IU Vitamin D3 (Cholecalciferol) will be given as one gelcaps every 2 weeks for a period of 6 months.
placeboDietary supplement
placebo will be given in identical gelcaps once every 2 weeks for a period of 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 | Active comparator | 50000 IU vitamin D3 capsule, one capsule every 2 weeks for 6 months. Receives: Dietary Supplement: Vitamin D3 (Cholecalciferol) |
| placebo | Placebo comparator | Placebo capsule, one capsule every 2 weeks for 6 months. Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical signs including abdominal pain, bloating, rumbling, abdominal distention, dissatisfaction with stool consistency
clinical signs will be assessed by Visual Analog Scale (VAS) 0-100mm self-report questionnaire at baseline and every two weeks for six months.
Measured: up to six months
Symptom Severity Score
symptom severity score will be assessed by IBS-Symptom Severity Score (IBS-SSS) self-report questionnaire baseline and after six months intervention.
Measured: up to six months
Secondary outcomes (15)
Dietary intake
24-Hour dietary recalls questionnaires will be used to assess dietary pattern at baseline and after 3 and 6 months intervention.
Measured: up to six months
Body Weight
Body Weight will be measured in kilograms at baseline and after six months intervention.
Measured: up to six months
Body Mass Index (BMI)
BMI is weight in kilograms divided to height in meters squared. It will be measured at baseline and after six months intervention.
Measured: up to six months
Waist Circumference (WC)
WC will be measured in centimeter at baseline and after six months intervention.
Measured: up to six months
Hip Circumference (HC)
HC will be measured in centimeter at baseline and after six months intervention.
Measured: up to six months
Waist to Hip Ratio (WHR)
WHR is WC divided to HC. It will be measured at baseline and after six months intervention.
Measured: up to six months
Blood Pressure (BP)
BP will be measured in mmHg at baseline and after six months intervention.
Measured: up to six months
Health-related Quality of Life
Health-Related Quality of Life will be assessed by IBS-Quality Of Life (IBS-QOL) with 34-item Short-Form (SF-34) self-report questionnaire at baseline and after six months intervention.
Measured: up to six months
Tumor Necrosis Factor-α (TNF-α)
Blood serum TNF-α will be assessed by enzyme-linked immunosorbent assay (ELISA) at baseline and after six months intervention.
Measured: up to six months
Interleukin-10 (IL-10)
Blood serum IL-10 will be assessed by ELISA at baseline and after six months intervention.
Measured: up to six months
Interleukin-17 (IL-17)
Blood serum IL-17 will be assessed by ELISA at baseline and after six months intervention.
Measured: up to six months
Malondialdehyde (MDA)
Blood serum MDA will be assessed by Thiobarbituric acid (TBA) method at baseline and after six months intervention.
Measured: up to six months
Total Antioxidant Capacity (TAC)
Blood serum TAC will be assessed by Ferric Reducing Antioxidant Power (FRAP) assay at baseline and after six months intervention.
Measured: up to six months
25-hydroxy vitamin D (25(OH)D)
Blood serum 25(OH)D will be assessed by Radioimmunoassay at baseline and after six months intervention.
Measured: up to six months
Calcium
Blood serum Calcium will be assessed by Arsenazo III method at baseline and after six months intervention
Measured: up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study startFeb 2015
- Primary completionAug 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahvaz Jundishapur University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir Abbasnezhad, Ahvaz Jundishapur University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02579902
- Sponsor's protocol ID
- ir.ajums.rec.1394.306
- Status last verified
- Nov 2015
- First submitted
- 11 Oct 2015
- Last updated
- 30 Nov 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin D3 Supplementation on Clinical Signs, Oxidative Stress and Inflammatory Biomarkers in Patients With Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT02579902
- Acronym / sponsor ID
- ir.ajums.rec.1394.306
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable Bowel Syndrome, inflammation, oxidative stress, clinical signs, vitamin D3
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ahvaz Jundishapur University of Medical SciencesUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 20 Oct 2015 (estimated)
- 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 purpose of this study is to determine whether vitamin D3 supplementation is effective in the treatment of clinical signs, biomarkers of inflammation and oxidative stress due to Irritable Bowel Syndrome (IBS).
Detailed description
This randomized double blind clinical trial will be performed on 90 patients (45 in intervention and 45 in control group) diagnosed with IBS. The intervention group will receive 50000 IU vitamin D3 and the control group will receive placebo contains edible paraffin once every 2 weeks for six months. Variables including biomarkers of inflammation and oxidative stress, serum levels of calcium and vitamin D, anthropometric indicators and blood pressure will be measured at baseline and end of the study. The investigators will use Rome III questionnaire for evaluating the clinical signs of the disease. The questionnaires will be filled out at baseline and every 2 weeks by the patients for six months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 | Active comparator | Dietary Supplement: Vitamin D3 (Cholecalciferol)50000 IU vitamin D3 capsule, one capsule every 2 weeks for 6 months. |
| placebo | Placebo comparator | Dietary Supplement: placeboPlacebo capsule, one capsule every 2 weeks for 6 months. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The patients who are diagnosed with Irritable Bowel Syndrome (IBS) according to ROME III criteria; Signed consent by the patient.
Key exclusion criteria (13 listed)
- Patients who have celiac disease (diagnosed by a duodenal biopsy or celiac serological tests)
- Any other diseases of the gastrointestinal tract such as Inflammatory Bowel Disease (IBD)
- Any kind of abdominal surgery
- Chronic disease such as diabetes
- Cardiovascular, hepatic
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 D3 (Cholecalciferol)50000 IU Vitamin D3 (Cholecalciferol) will be given as one gelcaps every 2 weeks for a period of 6 months. | Dietary supplement | Vitamin D3 |
| placeboplacebo will be given in identical gelcaps once every 2 weeks for a period of 6 months. | Dietary supplement | placebo |
Primary outcome
Clinical signs including abdominal pain, bloating, rumbling, abdominal distention, dissatisfaction with stool consistency
Time frame: up to six months
clinical signs will be assessed by Visual Analog Scale (VAS) 0-100mm self-report questionnaire at baseline and every two weeks for six months.
Symptom Severity Score
Time frame: up to six months
symptom severity score will be assessed by IBS-Symptom Severity Score (IBS-SSS) self-report questionnaire baseline and after six months intervention.
15 secondary outcomes
Dietary intake
Time frame: up to six months
Body Weight
Time frame: up to six months
Body Mass Index (BMI)
Time frame: up to six months
Waist Circumference (WC)
Time frame: up to six months
Hip Circumference (HC)
Time frame: up to six months
Waist to Hip Ratio (WHR)
Time frame: up to six months
Blood Pressure (BP)
Time frame: up to six months
Health-related Quality of Life
Time frame: up to six months
Tumor Necrosis Factor-α (TNF-α)
Time frame: up to six months
Interleukin-10 (IL-10)
Time frame: up to six months
Interleukin-17 (IL-17)
Time frame: up to six months
Malondialdehyde (MDA)
Time frame: up to six months
Total Antioxidant Capacity (TAC)
Time frame: up to six months
25-hydroxy vitamin D (25(OH)D)
Time frame: up to six months
Calcium
Time frame: up to six months
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 30 Nov 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vitamin D3 (Cholecalciferol) in people with Irritable Bowel Syndrome, run by Ahvaz Jundishapur University of Medical Sciences at 1 site in Iran.
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 1 inclusion and 13 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 30 Nov 2015. 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 Iran. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Clinical signs including abdominal pain, bloating, rumbling, abdominal distention, dissatisfaction with stool consistency (time frame: up to six months). The study lists 2 primary outcomes in all. 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 30 Nov 2015.