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Trial registered on ANZCTR


Registration number
ACTRN12617000836336
Ethics application status
Approved
Date submitted
31/05/2017
Date registered
7/06/2017
Date last updated
8/05/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Vitamin D supplementation in paediatric inflammatory bowel disease
Scientific title
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
Secondary ID [1] 292091 0
Nil known
Universal Trial Number (UTN)
U1111-1197-1534
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory Bowel Disease 303509 0
Condition category
Condition code
Inflammatory and Immune System 302925 302925 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 298234 0
Treatment: Other
Comparator / control treatment
Arm 1: single dose vitamin D supplement

Arm 2: No vitamin D supplement
Control group
Active

Outcomes
Primary outcome [1] 302318 0
Serum 25-hydroxyvitamin D (25OHD)
Timepoint [1] 302318 0
12 months post-intervention commencement
Secondary outcome [1] 335459 0
Compliance

Daily vitamin D compliance was assessed by patient recall of how many days in the week they consumed vitamin D oral supplement in week prior to clinic visit

Single dose vitamin D compliance reported by nurse observing the dosing
Timepoint [1] 335459 0
3 months, 6 months, 9 months post-intervention commencement
Secondary outcome [2] 335531 0
Weight (calibrated weight scales)
Timepoint [2] 335531 0
3 month, 6 month, 9 month post-intervention commencement
Secondary outcome [3] 335532 0
Height (calibrated stadiometer)
Timepoint [3] 335532 0
3 month, 6 month, 9 month post-intervention commencement
Secondary outcome [4] 335533 0
Serum parathyroid hormone (clinical laboratory measure)
Timepoint [4] 335533 0
3 month, 6 month, 9 month post-intervention commencement
Secondary outcome [5] 335534 0
Serum corrected calcium (clinical laboratory measure)
Timepoint [5] 335534 0
3 month, 6 month, 9 month post-intervention commencement
Secondary outcome [6] 335535 0
Serum Magnesium (clinical laboratory measure)
Timepoint [6] 335535 0
3 month, 6 month, 9 month post-intervention commencement
Secondary outcome [7] 335536 0
Serum phosphate (clinical laboratory measure)
Timepoint [7] 335536 0
3 month, 6 month, 9 month post-intervention commencement
Secondary outcome [8] 335537 0
Erythrocyte sedimentation rate (clinical laboratory measure)
Timepoint [8] 335537 0
3 month, 6 month, 9 month post-intervention commencement
Secondary outcome [9] 335538 0
Haemoglobin (clinical laboratory measure)
Timepoint [9] 335538 0
3 month, 6 month, 9 month post-intervention commencement
Secondary outcome [10] 335539 0
Haematocrit (clinical laboratory measure)
Timepoint [10] 335539 0
3 month, 6 month, 9 month post-intervention commencement
Secondary outcome [11] 335540 0
Platelets (clinical laboratory measure)
Timepoint [11] 335540 0
3 month, 6 month, 9 month post-intervention commencement
Secondary outcome [12] 335541 0
Albumin (clinical laboratory measure)
Timepoint [12] 335541 0
3 month, 6 month, 9 month post-intervention commencement
Secondary outcome [13] 335542 0
Alkaline phosphatase (clinical laboratory measure)
Timepoint [13] 335542 0
3 month, 6 month, 9 month post-intervention commencement
Secondary outcome [14] 335543 0
Aspartate aminotransferase (clinical laboratory measure)
Timepoint [14] 335543 0
3 month, 6 month, 9 month post-intervention commencement
Secondary outcome [15] 335544 0
Alanine aminotransferase (clinical laboratory measure)
Timepoint [15] 335544 0
3 month, 6 month, 9 month post-intervention commencement
Secondary outcome [16] 335545 0
C reactive protein (clinical laboratory measure)
Timepoint [16] 335545 0
3 month, 6 month, 9 month post-intervention commencement
Secondary outcome [17] 335546 0
Pediatric Crohns Disease Activity index
Timepoint [17] 335546 0
3 month, 6 month, 9 month post-intervention commencement
Secondary outcome [18] 335547 0
Modified Pediatrics Crohns Disease Activity Index
Timepoint [18] 335547 0
3 month, 6 month, 9 month post-intervention commencement
Secondary outcome [19] 335548 0
Pediatric Ulcerative Colitis Activity Index
Timepoint [19] 335548 0
3 month, 6 month, 9 month post-intervention commencement
Secondary outcome [20] 335549 0
Quality of Life (Impact III questionnaire)
Timepoint [20] 335549 0
3 month, 6 month, 9 month post-intervention commencement

Eligibility
Key inclusion criteria
Aged 5-18 years
Diagnosis of Inflammatory Bowel Disease
Minimum age
5 Years
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current treatment for hypovitaminosis D, renal or liver failure
Raised serum calcium
Hyperparathyroidism

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involved contacting the holder of the allocation schedule at central administration site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
This was a 2 Arm study. Participants were directed into either Arm based on serum 25OHD levels at baseline. Participants with 25OHD levels <50 nmol/L were classified vitamin D deficient and directed into Arm 1. Participants who were >=50 nmol/L were classified as vitamin D sufficient and directed into Arm 2.
Phase
Not Applicable
Type of endpoint(s)
Bio-availability
Statistical methods / analysis
Standard statistical methods will be applied, i.e. establish whether variable is parametric/non-parametric and apply appropriate statistical test. Initially treatments arms will be analysed separately. Initial analysis will compare whether the primary outcome (12 month vitamin D levels) is significantly different between treatments for each arm and will be used to determine the outcome of the clinical trial.
Secondary outcomes (Secondary outcomes are vitamin D level at 3, 6 and 9 months follow-up as well as serum calcium levels, serum and faecal inflammatory markers, disease activity scores QOL (IMPACT III) and growth parameters and all time points. Also when appropriate, analysis will be attempted by comparing variables between treatment arms when considered scientifically and/or clinically appropriate.


Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 8222 0
Sydney Children's Hospital - Randwick
Recruitment postcode(s) [1] 16281 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 296622 0
Hospital
Name [1] 296622 0
Department of Gastroenterology Sydney Children's Hospital
Address [1] 296622 0
High Street, Randwick
Sydney, NSW, 2031
Australia
Country [1] 296622 0
Australia
Primary sponsor type
Hospital
Name
Sydney Children's Hospital
Address
High Street, Randwick
Sydney, NSW, 2031
Australia
Country
Australia
Secondary sponsor category [1] 295585 0
None
Name [1] 295585 0
Address [1] 295585 0
Country [1] 295585 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297855 0
Sydney Children's Hospital Network Human Research Ethics Committee
Ethics committee address [1] 297855 0
Corner of Hawksbury Road and Hainsworth Street
Westmead NSW 2145
Ethics committee country [1] 297855 0
Australia
Date submitted for ethics approval [1] 297855 0
23/05/2014
Approval date [1] 297855 0
09/10/2014
Ethics approval number [1] 297855 0
HREC/14/SCHN/10

Summary
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.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75274 0
A/Prof Daniel Lemberg
Address 75274 0
Executive Wing, Level 4
Sydney Children's Hospital
High Street, Randwick
NSW, 2031
Country 75274 0
Australia
Phone 75274 0
+61 2 9382 1111
Fax 75274 0
Email 75274 0
avi.lemberg@sesiahs.health.gov.nsw.au
Contact person for public queries
Name 75275 0
Dr Steven Leach
Address 75275 0
Westfield Research Laboratories, Level 2
Sydney Children's Hospital
High Street, Randwick
NSW, 2031
Country 75275 0
Australia
Phone 75275 0
+61 2 9382 1883
Fax 75275 0
Email 75275 0
s.leach@unsw.edu.au
Contact person for scientific queries
Name 75276 0
Dr Steven Leach
Address 75276 0
Westfield Research Laboratories, Level 2
Sydney Children's Hospital
High Street, Randwick
NSW, 2031
Country 75276 0
Australia
Phone 75276 0
+61 2 9382 1884
Fax 75276 0
Email 75276 0
s.leach@unsw.edu.au

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary