An interventional study of Vitamin D3 and Placebo in Irritable Bowel Syndrome (IBS) and Vitamin D Deficiency, sponsored by Aziz Bhatti Shaheed Teaching Hospital. Recruiting at 1 site in Pakistan. Open to participants aged 6 Years to 14 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Aziz Bhatti Shaheed Teaching Hospital · Not applicable, Interventional, and Supportive care
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.
1,116 studies on the registry are indexed under Irritable Bowel Syndrome; 208 are open to participants now.
This study's planned enrollment of 48 is below the median of 70 across 896 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →This is the only study on the registry with Aziz Bhatti Shaheed Teaching Hospital as lead sponsor.
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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.
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Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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Participants received oral vitamin D3 drops containing 2,000 international units once daily for 12 weeks, alongside standard supportive care for irritable bowel syndrome.
Drug: Vitamin D3
Participants received matching placebo drops orally once daily for 12 weeks, alongside standard supportive care for irritable bowel syndrome.
Drug: Placebo
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.
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.
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.
Time frame: Baseline and 12 weeks after treatment initiation
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.
Time frame: Baseline and 12 weeks after treatment initiation.
Started Sep 2026 (actual). Primary completion is estimated for Mar 2027, 6 months after the start.
Of 305 non-industry interventional studies with no phase under Irritable Bowel Syndrome, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 40. This study's planned 6 months is below that.
Counting every sponsor, half of 357 studies reached it within 19 months; a quarter within 9 and three quarters within 38.
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 ↗
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