None listed
Conditions
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
Interventions
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 µ
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.
Sponsors
Australian Catholic University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
Male
Age
18 Years to 24 Years
Healthy volunteers
Yes
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.
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
Outcome results
None listed