ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Low bone density

Condition category

Condition code

Musculoskeletal

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]

Prevention

Intervention code [2]

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]

Strength Strain Index (surrogate measure of bone strength) using peripheral quantitative computed tomography (pQCT)

Timepoint [1]

Baseline and 6 months

Secondary outcome [1]

Volumetric cortical bone density measured using peripheral quantitative computed tomography (pQCT)

Timepoint [1]

Baseline and 6 months

Secondary outcome [2]

Trabecular density measured using peripheral quantitative computed tomography (pQCT)

Timepoint [2]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

University

Name [1]

Australian Catholic University

Address [1]

Locked Bag 2002, Strathfield NSW 2135

Country [1]

Australia

Primary sponsor type

University

Name

Australian Catholic University

Address

Locked Bag 2002, Strathfield NSW 2135

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Higher Research Ethics Committee - Australian Catholic University

Ethics committee address [1]

Locked Bag 2002, Strathfield NSW 2135

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/05/2012

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

David Greene

Address

Locked Bag 2002, Strathfield NSW 2135

Country

Australia

Phone

61297014377

Fax

david.greene@acu.edu.au

Contact person for scientific queries

Name

David Greene

Address

Locked Bag 2002, Strathfield NSW 2135

Country

Australia

Phone

61297014377

Fax

david.greene@acu.edu.au

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

Source	Title	Year of Publication	DOI
Embase	Tibial bone responses to 6-month calcium and vitamin D supplementation in young male jockeys: A randomised controlled trial.	2015	https://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.

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Documents added manually

Documents added automatically