Vitamin D Supplementation in Children with Irritable Bowel Syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, placebo-controlled trial recruited 60 children aged 6–14 with irritable bowel syndrome and vitamin D insufficiency or deficiency. Participants were assigned to receive either daily vitamin D3 drops (2000 IU) or placebo for 12 weeks, in addition to standard supportive care. The goal was to see if vitamin D supplementation would reduce symptom severity and raise blood 25-hydroxyvitamin D levels. The study was conducted at Aziz Bhatti Shaheed Teaching Hospital in Gujrat, Pakistan. Eligibility included Rome IV-confirmed IBS and vitamin D levels between 10–29 ng/mL, with clear exclusion for other organic GI diseases.

Why it matters

Who can join: the full rules

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.

Where it's running

• Aziz Bhatti Shaheed Teaching Hospital
  Gujrat, Punjab Province, Pakistan Recruiting

Study contacts

• Principal investigator: Imaan Tahir — Aziz Bhatti Shaheed Teaching Hospital
• Study coordinator: Imaan Tahir
• Email: imaantahir105@gmail.com
• Phone: +92 308 1850511

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.