RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: testing Vitamin D3 for Irritable Bowel Syndrome (IBS)

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 dummy treatment (placebo).

Official registry: https://clinicaltrials.gov/study/NCT07914478 · Aziz Bhatti Shaheed Teaching Hospital · enrollment listed as 48

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Vitamin D3, or Placebo. The registry lists allocation as randomized. 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.

They plan to enroll about 48 people at Gujrat. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: Vitamin D3, Placebo

Primary outcome (registry wording): Change in Irritable Bowel Syndrome Symptom Severity Score

Who it is for (from inclusion criteria)

Ages 6 Years to 14 Years
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

Who the registry excludes

Children with vitamin D deficiency or normal/sufficient vitamin D level
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

Public study contact (from the registry)

Imaan Tahir

+92 308 1850511

imaantahir105@gmail.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

Aziz Bhatti Shaheed Teaching Hospital — Gujrat, Punjab Province, Pakistan (recruiting)

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FAQ about this NCT record

Is NCT07914478 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07914478?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07914478?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary