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NCT07914478

Role of Vitamin D Supplementation in Children With Irritable Bowel Syndrome

Sponsor: Aziz Bhatti Shaheed Teaching Hospital

View on ClinicalTrials.gov

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. 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.

Official title: Role of Vitamin D Supplementation in Children With Irritable Bowel Syndrome: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

6 Years - 14 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-09-01

Completion Date

2027-03-30

Last Updated

2026-11-03

Healthy Volunteers

Conditions

Irritable Bowel Syndrome (IBS)Vitamin D Deficiency

Interventions

DRUG

Vitamin D3

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.

DRUG

Placebo

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.

Inclusion Criteria: * 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 Criteria: * 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.

Locations (1)

Aziz Bhatti Shaheed Teaching Hospital

Gujrat, Punjab Province, Pakistan