Building bone from blood: The effect of vitamin D on circulating bone-forming cells

• Register: ANZCTR
• Last refreshed on: 1 November 2021
• Main ID: ACTRN12617000570381
• Date of registration: 24/04/2017
• Prospective Registration: Yes
• Primary sponsor: Western Health
• Public title: Building bone from blood: The effect of vitamin D on circulating bone-forming cells
• Scientific title: A randomised, double blind, placebo-controlled trial to determine the effect of vitamin D supplementation on the number of Circulating Osteo-Progenitor (COP) cells in vitamin D-deficient individuals
• Date of first enrolment: 01/07/2019
• Target sample size: 84
• Recruitment status: Stopped early
• URL: https://anzctr.org.au/ACTRN12617000570381.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Phase 4

Countries of recruitment

Australia

Contacts

• Name: Dr Karin du Plessis

• Name: Dr Elizabeth Liberts

Key inclusion & exclusion criteria

Inclusion criteria: 1- Age > 55yo
2- Both male and females
3- Independent in Activities of Daily Living (ADL) (Barthel > 60%)
4- Vitamin D deficient < 35 nmol/L
5- Normal Bone Mineral Density (BMD) (>-1 SD)
Exclusion criteria: 1- Current smoker
2- High Body Mass Index (>30)
3- Diabetics
4- Hematopoietic / Hematological diseases
5- Current or prior use of drugs that could interfere with bone mass (ie Glucocorticosteroids, anti-resorptive drugs, Hormone Replacement Therapy, Teriparatide)
6- History of recent / traumatic fractures in the last 3 months
7- History of bone tumours
8- Aortic valve calcification
9- HyperPTH (>6.8pmol/L)
10- Abnormal thyroid function (Thyroid Stimulating Hormone (TSH) > 10mIU/L)
11- Estimated Glomerular Filtration rate (eGFR) < 35 ml/min

Age minimum: 55 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Musculoskeletal - Other muscular and skeletal disorders

Vitamin D deficiency;
Vitamin D deficiency

Intervention(s)

After randomisation, on day 1 of the 3 month dosing period, participants will be given either loading dose of one tablet containing 50000IU of vitamin D orally (treated group - Arm 1) or a tablet containing placebo (placebo group - Arm 2). Both groups will also receive 1000IU/day of vitamin D for 3 months starting on day 1 post-loading dose for both groups. Participants will be required to return every 4 weeks for a total of 3 monthly visits. During each monthly visit, adherence will be monitored by asking the participants to bring their empty bottles of vitamin D tablets. At their monthly visits, participants will receive enough vitamin D tablets (1,000 IU/tablet) for a month. In addition, a monthly blood test (40ml) will be performed.

Primary Outcome(s)

The primary outcome of the intervention will be the proportion of participants with an increase in number of circulating osteoprogenitor cells (COP) cells (as a percentage), measure by flow cytometry, at the end of the first month post-loading dose.
[One month post-loading dose (50,000 IU) of vitamin D]

Secondary Outcome(s)

The secondary outcome would be to observe the rate of increase (monthly) of COP cells for three months. Percentage of COP cells in the circulation will be mesured monthly by flow cytometry.[At 1, 2 and 3 months post-loading dose]

Secondary ID(s)

None

Source(s) of Monetary Support

The University of Melbourne

Ethics review

Status: Approved
Approval date: 10/02/2017
Contact:

MELBOURNE HEALTH HUMAN RESEARCH ETHICS COMMITTEE

Results

• Date Posted: 28/10/2021