Vitamin D supplementation in paediatric inflammatory bowel disease

Vitamin D supplementation in paediatric inflammatory bowel disease: A randomised controlled trial to determine effect of vitamin D status and supplementation method on serum 25-hydroxyvitamin D levels

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12617000836336

Enrollment

180

Registered

2017-06-07

Start date

2015-05-07

Completion date

2017-09-14

Last updated

2020-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Vitamin D has been increasingly recognised to play a part in immunomodulation and could have a possible role in IBD pathogenesis. However, only one randomised controlled trial has been conducted to date that used vitamin D supplementation as the main intervention in IBD paediatrics patients. This study investigated the efficacy and safety of vitamin D supplementations in vitamin D deficient pediatric IBD patient for 6 weeks. In this study patients were randomized into one of the three arms – 2000IU vitamin D2 daily, 2000IU vitmain D3 daily and 50,000IU vitamin D2 weekly. The outcomes were determined by 25OHD levels and secondary change in parathyroid hormone and adverse events. Another similar study was undertaken in adult Crohn’s disease patients and investigated the effects of vitamin D on improved disease course. This current proposal is unique in that it will compare vitamin D supplementation method (daily dosing vs a single high dose) in IBD, which has not previously been addressed in the literature. Further, the proposal will add to the literature in that there is a one year follow-up which will provide longer term observation of the effects of vitamin D supplementations in pediatric IBD. In addition this study will specifically address the question of whether additional vitamin D supplementation can improve disease activity in patients in a specifically defined Vitamin D sufficient group. In conclusion, vitamin D is generally well-tolerated and adverse effects in these clinical trials were mild and non-specific. None of the studies required withdrawal of subjects due to adverse events from vitamin D intake regardless of their 25OHD levels at the point of recruitment.

Interventions

Vitamin D supplement (Cholecaliferol) 1000 international units (IU) per oral tablet Vitamin D supplement (Calciferol Strong) 50,000 IU (1.25mg) per oral chew able tablet Arm 1 Intervention 1: Age independent 2000 IU (2 x 1000 IU oral tablets) daily for 12 months Intervention 2: Age <3 year 200,000 IU (4 x 50,000 IU oral tablets) single dose at start of trail Age 3-12 years 400,000 (8 x 50,000 IU oral tablets) single dose at start of trail Age 12 + years 800,000 (16 x 50,000 IU oral tablets) single dose at start of trail Following initial dose, participants will be assessed every 3 months by their treating physician as to whether a further single high dose of vitamin D is required Arm 2: Intervention 1: Age independent 2000 IU (2 x 1000 IU oral tablets) daily for 12 months Intervention 2: No intervention

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

5 Years to 18 Years

Healthy volunteers

Inclusion criteria

Aged 5-18 years Diagnosis of Inflammatory Bowel Disease

Exclusion criteria

Current treatment for hypovitaminosis D, renal or liver failure Raised serum calcium Hyperparathyroidism

Outcome results