Irritable Bowel Syndrome (IBS)NCT07914478
Role of Vitamin D Supplementation in Children With Irritable Bowel Syndrome
A study testing Vitamin D3 in people with Irritable Bowel Syndrome (IBS) and Vitamin D Deficiency, run by Aziz Bhatti Shaheed Teaching Hospital at 1 site in Pakistan.
Trial summary
This study was designed to determine whether vitamin D supplementation improved symptoms in children with irritable bowel syndrome, a condition associated with repeated abdominal pain and changes in bowel habits. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Irritable Bowel Syndrome (IBS), Vitamin D Deficiency
- What is being tested?
- Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2026to 30 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 6 to 14 years of either gender.
- Children diagnosed with irritable bowel syndrome according to Rome IV criteria as per operational definition.
- Children belonging to any irritable bowel syndrome subtype, including IBS with constipation, IBS with diarrhea, mixed IBS, and unsubtyped IBS.
- Children with serum 25-hydroxyvitamin D levels between 10 and 29 ng/mL, including vitamin D deficiency defined as 10-19 ng/mL and vitamin D insufficiency defined as 20-29 ng/mL.
- Children with symptoms present for at least 2 months prior to enrollment.
- Children who are able to take oral vitamin D supplementation and attend follow-up visits.
- Children whose parents or legal guardians provide written informed consent, with assent from the child where appropriate.
Who cannot join
- Children with vitamin D deficiency or normal/sufficient vitamin D level.
- Children with evidence of organic gastrointestinal disease, including inflammatory bowel disease, celiac disease, peptic ulcer disease, gastrointestinal tuberculosis, chronic liver disease, pancreatic disease, intestinal obstruction, Hirschsprung disease, or gastrointestinal malignancy.
- Children having alarm features suggestive of organic pathology, including: unintentional weight loss, growth failure or short stature, persistent fever, gastrointestinal bleeding, including hematemesis, melena, or blood in stool, chronic severe diarrhea, unexplained anemia, organomegaly
- Children with chronic systemic illness that may affect vitamin D metabolism or gastrointestinal symptoms, including chronic kidney disease, nephrotic syndrome, hyperparathyroidism, malabsorption syndrome, metabolic bone disease, or endocrine disorders.
- Children receiving vitamin D supplements, calcium supplements, multivitamins containing vitamin D, corticosteroids, anticonvulsants, rifampicin, or other drugs affecting vitamin D metabolism within the last 8 weeks.
- Children with acute gastrointestinal infection at the time of assessment.
- Children with severe neurodevelopmental, psychiatric, or communication disorders making reliable symptom assessment difficult.
- Children with a history of major abdominal surgery likely to affect bowel function.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Aziz Bhatti Shaheed Teaching Hospital
Gujrat, Punjab Province, 54000
Imaan Tahir, +92 308 1850511, imaantahir105@gmail.com
About this study
Official title: Role of Vitamin D Supplementation in Children With Irritable Bowel Syndrome: A Randomized Controlled Trial
This study was designed to determine whether vitamin D supplementation improved symptoms in children with irritable bowel syndrome, a condition associated with repeated abdominal pain and changes in bowel habits. It was hypothesized that vitamin D supplementation would reduce symptom severity and increase blood vitamin D levels compared with placebo.
The study was a randomized, placebo-controlled trial at the Department of Pediatrics, Aziz Bhatti Shaheed Teaching Hospital, Gujrat, Pakistan. It included 60 children aged 6-14 years who met established diagnostic criteria for irritable bowel syndrome and had low blood vitamin D levels of 10-29 ng/mL. Children were randomly assigned to two groups of 30 participants each. One group received oral vitamin D3 drops containing 2,000 international units once daily for 12 weeks. The other group received matching placebo drops without vitamin D for the same period. Both groups received routine supportive care, including advice on hydration, regular meals, diet, and symptom management.
Follow-up visits were scheduled at 4, 8, and 12 weeks to assess symptoms, treatment adherence, and possible side effects. The main outcome was the change in symptom severity from the start of treatment to 12 weeks, measured using a standardized symptom score. The secondary outcome was the change in blood vitamin D levels over the same period. Changes in both outcomes were compared between the two groups.
- Being tested
- Vitamin D3, Placebo
- Keywords
- Pediatric irritable bowel syndrome, Vitamin D supplementation, Cholecalciferol, Vitamin D insufficiency, Children
- Medical subject headings
- Irritable Bowel Syndrome, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Drug
Vitamin D3 drops were administered orally at a dose of 2,000 international units once daily for 12 weeks, preferably after a meal, using a calibrated dropper. Standard supportive care included hydration advice, regular meals, dietary guidance according to symptoms, and parental home-care instructions.
PlaceboDrug
Placebo drops were administered orally once daily for 12 weeks, matching the vitamin D3 drops in volume, appearance, and packaging. Participants received the same standard supportive care, including hydration advice, regular meals, dietary guidance according to symptoms, and parental home-care instructions.
| Study group | Role | What they receive |
|---|---|---|
| Group A - Vitamin D3 | Experimental | Participants received oral vitamin D3 drops containing 2,000 international units once daily for 12 weeks, alongside standard supportive care for irritable bowel syndrome. Receives: Drug: Vitamin D3 |
| Group B - Placebo | Placebo comparator | Participants received matching placebo drops orally once daily for 12 weeks, alongside standard supportive care for irritable bowel syndrome. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Irritable Bowel Syndrome Symptom Severity Score
Symptom severity was assessed using the Irritable Bowel Syndrome Severity Scoring System, with total scores ranging from 0 to 500. Higher scores indicated greater symptom severity. The change was calculated as the score at 12 weeks minus the baseline score; a negative change indicated improvement. The mean change was compared between the vitamin D3 and placebo groups.
Measured: Baseline and 12 weeks after treatment initiation
Secondary outcomes (1)
Change in Serum 25-Hydroxyvitamin D Level
Serum 25-hydroxyvitamin D was measured in venous blood samples and expressed in ng/mL. The change was calculated as the concentration at 12 weeks minus the baseline concentration; a positive change indicated an increase in serum vitamin D level. The mean change was compared between the vitamin D3 and placebo groups.
Measured: Baseline and 12 weeks after treatment initiation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start1 Sep 2026
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel Syndrome (IBS)Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aziz Bhatti Shaheed Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Imaan Tahir, Aziz Bhatti Shaheed Teaching Hospital
- Investigators
- Imaan Tahir, Principal investigator, Aziz Bhatti Shaheed Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07914478
- Sponsor's protocol ID
- ABSH1
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Vitamin D Supplementation in Children With Irritable Bowel Syndrome: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07914478
- Acronym / sponsor ID
- ABSH1
- Keywords
- Pediatric irritable bowel syndrome, Vitamin D supplementation, Cholecalciferol, Vitamin D insufficiency, Children
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Aziz Bhatti Shaheed Teaching HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 3 Nov 2026 (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.
This study was designed to determine whether vitamin D supplementation improved symptoms in children with irritable bowel syndrome, a condition associated with repeated abdominal pain and changes in bowel habits. It was hypothesized that vitamin D supplementation would reduce symptom severity and increase blood vitamin D levels compared with placebo.
The study was a randomized, placebo-controlled trial at the Department of Pediatrics, Aziz Bhatti Shaheed Teaching Hospital, Gujrat, Pakistan. It included 60 children aged 6-14 years who met established diagnostic criteria for irritable bowel syndrome and had low blood vitamin D levels of 10-29 ng/mL. Children were randomly assigned to two groups of 30 participants each. One group received oral vitamin D3 drops containing 2,000 international units once daily for 12 weeks. The other group received matching placebo drops without vitamin D for the same period. Both groups received routine supportive care, including advice on hydration, regular meals, diet, and symptom management.
Follow-up visits were scheduled at 4, 8, and 12 weeks to assess symptoms, treatment adherence, and possible side effects. The main outcome was the change in symptom severity from the start of treatment to 12 weeks, measured using a standardized symptom score. The secondary outcome was the change in blood vitamin D levels over the same period. Changes in both outcomes were compared between the two groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A - Vitamin D3 | Experimental | Drug: Vitamin D3Participants received oral vitamin D3 drops containing 2,000 international units once daily for 12 weeks, alongside standard supportive care for irritable bowel syndrome. |
| Group B - Placebo | Placebo comparator | Drug: PlaceboParticipants received matching placebo drops orally once daily for 12 weeks, alongside standard supportive care for irritable bowel syndrome. |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children aged 6 to 14 years of either gender.
- Children diagnosed with irritable bowel syndrome according to Rome IV criteria as per operational definition.
- Children belonging to any irritable bowel syndrome subtype, including IBS with constipation, IBS with diarrhea, mixed IBS, and unsubtyped IBS.
- Children with serum 25-hydroxyvitamin D levels between 10 and 29 ng/mL, including vitamin D deficiency defined as 10-19 ng/mL and vitamin D insufficiency defined as 20-29 ng/mL.
- Children with symptoms present for at least 2 months prior to enrollment.
Key exclusion criteria (8 listed)
- Children with vitamin D deficiency or normal/sufficient vitamin D level.
- Children with evidence of organic gastrointestinal disease, including inflammatory bowel disease, celiac disease, peptic ulcer disease, gastrointestinal tuberculosis, chronic liver disease, pancreatic disease, intestinal obstruction, Hirschsprung disease, or gastrointestinal malignancy.
- Children having alarm features suggestive of organic pathology, including: unintentional weight loss, growth failure or short stature, persistent fever, gastrointestinal bleeding, including hematemesis, melena, or blood in stool, chronic severe diarrhea, unexplained anemia, organomegaly
- Children with chronic systemic illness that may affect vitamin D metabolism or gastrointestinal symptoms, including chronic kidney disease, nephrotic syndrome, hyperparathyroidism, malabsorption syndrome, metabolic bone disease, or endocrine disorders.
- Children receiving vitamin D supplements, calcium supplements, multivitamins containing vitamin D, corticosteroids, anticonvulsants, rifampicin, or other drugs affecting vitamin D metabolism within the last 8 weeks.
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 D3Vitamin D3 drops were administered orally at a dose of 2,000 international units once daily for 12 weeks, preferably after a meal, using a calibrated dropper. Standard supportive care included hydration advice, regular meals, dietary guidance according to symptoms, and parental home-care instructions. | Drug | Group A - Vitamin D3 |
| PlaceboPlacebo drops were administered orally once daily for 12 weeks, matching the vitamin D3 drops in volume, appearance, and packaging. Participants received the same standard supportive care, including hydration advice, regular meals, dietary guidance according to symptoms, and parental home-care instructions. | Drug | Group B - Placebo |
Primary outcome
Change in Irritable Bowel Syndrome Symptom Severity Score
Time frame: Baseline and 12 weeks after treatment initiation
Symptom severity was assessed using the Irritable Bowel Syndrome Severity Scoring System, with total scores ranging from 0 to 500. Higher scores indicated greater symptom severity. The change was calculated as the score at 12 weeks minus the baseline score; a negative change indicated improvement. The mean change was compared between the vitamin D3 and placebo groups.
1 secondary outcome
Change in Serum 25-Hydroxyvitamin D Level
Time frame: Baseline and 12 weeks after treatment initiation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
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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.
Imaan Tahir principal investigator
Aziz Bhatti Shaheed Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 in people with Irritable Bowel Syndrome (IBS) and Vitamin D Deficiency, run by Aziz Bhatti Shaheed Teaching Hospital at 1 site in Pakistan.
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 7 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 3 Nov 2026. 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Imaan Tahir (+92 308 1850511, imaantahir105@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Irritable Bowel Syndrome Symptom Severity Score (time frame: Baseline and 12 weeks after treatment initiation). 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 3 Nov 2026.