Role of Vitamin D Supplementation in Children With Irritable Bowel Syndrome
Key facts
- Where
- Gujrat, PakistanSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 6 and 14 years old?
Source: NCT07914478, who can take part
Where in Pakistan
- Aziz Bhatti Shaheed Teaching HospitalGujrat, PakistanContact: Imaan TahirTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Aziz Bhatti Shaheed Teaching Hospital
- Trial code
- NCT07914478
- Record updated
- 3 November 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: 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 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; 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 vitamin D deficiency or normal/sufficient vitamin D level.