Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000374864
Ethics application status
Not yet submitted
Date submitted
30/03/2012
Date registered
2/04/2012
Date last updated
2/04/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Calcium and vitamin-D supplementation on bone structural properties in young male Jockeys: A randomized controlled trial.
Scientific title
For young male jockeys, will 6-month calcium and vitamin D supplementation compared to a placebo increase tibial and radial bone strength and density
Secondary ID [1] 280235 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low bone density 286185 0
Condition category
Condition code
Musculoskeletal 286381 286381 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the active group will receive 800 mg calcium (citrate and carbonate) and 400 IU vitamin D in tablet form per day (USANA Pty Ltd, Sydney, Australia) for a period of 6 months.

Each Tablet Contains:
Calcium (equiv 200 mg) As
Calcium citrate hydrate 371 mg
Calcium carbonate 304 mg
Magnesium (equiv 100 mg) as
Magnesium citrate 370 mg
Magnesium amino acid chelate 83 mg
Magnesium oxide 82 mg
Cholecalciferol (vitamin D3, 100 IU ) 2.5 µg
Phytomenadine (Vitamin K) 15 µg

Participants will choose their preferred method of communication to receive a monthly reminder notice (eg: text message, email, standard letter). The reminder notice will be a brief message (approximately 2 - 3 sentences) thanking the participants for their ongoing involvement in the study and encouraging them to continue taking their supplement. The message will also contain contact details of the Chief Investigator if any participant is experiencing any problems.
Intervention code [1] 284572 0
Prevention
Intervention code [2] 284573 0
Treatment: Other
Comparator / control treatment
Participants in the placebo groups will be asked to consume 4 tablets per day that is identical in taste, texture, and colour as the active groups but does not contain active ingredients for 6 months.

The placebo tablet contains:
Microcrystalline cellulose 814.42
Pregelatinized starch 56.82
Croscarmellose sodium 37.88
Ascorbyl palmitate 18.94
Colloidal Silicon Dioxide 18.94
Dextrin 6.90363
Dextrose 0.95647
Lecithin 0.947
Sodium CMC 0.4735
Sodium Citrate 0.1894

Participants will choose their preferred method of communication to receive a monthly reminder notice (eg: text message, email, standard letter). The reminder notice will be a brief message (approximately 2 - 3 sentences) thanking the participants for their ongoing involvement in the study and encouraging them to continue taking their supplement. The message will also contain contact details of the Chief Investigator if any participant is experiencing any problems.
Control group
Placebo

Outcomes
Primary outcome [1] 286839 0
Strength Strain Index (surrogate measure of bone strength) using peripheral quantitative computed tomography (pQCT)
Timepoint [1] 286839 0
Baseline and 6 months
Secondary outcome [1] 296797 0
Volumetric cortical bone density measured using peripheral quantitative computed tomography (pQCT)
Timepoint [1] 296797 0
Baseline and 6 months
Secondary outcome [2] 296798 0
Trabecular density measured using peripheral quantitative computed tomography (pQCT)
Timepoint [2] 296798 0
Baseline and 6 months

Eligibility
Key inclusion criteria
Jockey currently completing, or have completed, Certificate IV in Racing in New South Wales
Caucasian ethnicity
In good health with no systemic illness lasting more than 2 weeks in last 6 months
No known history of fracture or recurrent fracture complications in last 6 months
No known history of metabolic bone or muscle disease.
No bone enhancing medication eg: bisphosponates, hormones or calcium/vitamin D preparations in preceding 6 months and willing to remain free of such medications for the 6 months of data collection.
Minimum age
18 Years
Maximum age
24 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Systemic illness lasting more than 2 weeks in last 6 months
Fracture or recurrent fracture complications in last 6 months
History of metabolic bone or muscle disease.
Consumption of bone enhancing medication eg: bisphosponates, hormones or calcium/vitamin D preparations in preceding 6 months

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Jockeys aged 18 to 24 years who are currently completing, or have completed, Certificate IV in Racing in New South Wales (NSW) will be invited to participate.

Adaptive randomisation stratified for maturation will be used to assign participants to the active or placebo group. Allocation concealment will be achieved using opaque envelopes. Participants and researchers will be blinded to group allocation and to supplement type. Active and placebo supplements will be identical in colour, taste, and appearance. All participants will take the supplement daily with a meal of their choice for 6 months and will receive identical monthly reminders via their preferred method of communication (text message, email, or letter).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be undertaken using a computer-generated sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284996 0
University
Name [1] 284996 0
Australian Catholic University
Country [1] 284996 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
Locked Bag 2002, Strathfield NSW 2135
Country
Australia
Secondary sponsor category [1] 283860 0
None
Name [1] 283860 0
Address [1] 283860 0
Country [1] 283860 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 287002 0
Higher Research Ethics Committee - Australian Catholic University
Ethics committee address [1] 287002 0
Locked Bag 2002, Strathfield NSW 2135
Ethics committee country [1] 287002 0
Australia
Date submitted for ethics approval [1] 287002 0
01/05/2012
Approval date [1] 287002 0
Ethics approval number [1] 287002 0

Summary
Brief summary
We propose to conduct a 6-month, randomised, double-blinded placebo-controlled trial to assess the effectiveness of daily calcium and vitamin D supplementation in improving bone material properties at the distal tibia and radius in young male jockeys. The three-dimensional capacity of peripheral quantitative computed tomography (pQCT) to assess bone strength and estimates of fracture risk will be superior to previous reports using Dual X-ray Absorptiometry and will contribute new knowledge to the literature. Bone scans at baseline and 6-months will provide a better understanding of the relationship between supplementation and bone properties, including fracture risk.

Project Aims
We will test the hypothesis that 800 mg calcium (citrate and carbonate) and 400 IU vitamin D per day is effective in improving bone material properties and reducing fracture risk in young male jockeys by;
(i) comparing changes to strength stain index (bone strength) at the tibia and radius in participants assigned to receive a 6-month calcium and vitamin D supplementation or a placebo
Secondary aims are to:
(i) monitor the proportion of young male jockeys who meet the recommended daily intake of calcium (1300 mg/day)
(ii) compare the effects of supplementation on weight-bearing (tibia) and non weight-bearing (radius and ulna) bones
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31034 0
Address 31034 0
Country 31034 0
Phone 31034 0
Fax 31034 0
Email 31034 0
Contact person for public queries
Name 14281 0
David Greene
Address 14281 0
Locked Bag 2002, Strathfield NSW 2135
Country 14281 0
Australia
Phone 14281 0
61297014377
Fax 14281 0
Email 14281 0
[email protected]
Contact person for scientific queries
Name 5209 0
David Greene
Address 5209 0
Locked Bag 2002, Strathfield NSW 2135
Country 5209 0
Australia
Phone 5209 0
61297014377
Fax 5209 0
Email 5209 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseTibial bone responses to 6-month calcium and vitamin D supplementation in young male jockeys: A randomised controlled trial.2015https://dx.doi.org/10.1016/j.bone.2015.09.004
N.B. These documents automatically identified may not have been verified by the study sponsor.