Building bone from blood: The relationship between Vitamin D and Circulating Osteoprogenitor (COP) cells – A pilot study

Building bone from blood: The relationship between Vitamin D and Circulating Osteoprogenitor (COP) cells – A pilot study in otherwise healthy adults with varying levels of Vitamin D, from deficient to sufficient

Status

Suspended

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12619000685112

Enrollment

Registered

2019-05-07

Start date

2019-07-10

Completion date

2020-03-20

Last updated

2020-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This project is investigating the relationship between vitamin D levels, and a recently discovered stem cell called a circulating osteogenic precursor (COP) cell. COP cells are stem cells found in the circulating blood, with the capacity to form bone as well as other tissues such as fat, muscle and cartilage. It is hoped that these cells might be used to treat and manage a range of bone diseases such as fractures and osteoporosis (brittle bones). Vitamin D is known to be important in maintaining bone health, and this trial hopes to uncover whether COP cells play a role in this. This pilot study aims to help us to understand the relationship between vitamin D and COP cells, so that we can plan and run a successful large trial in the future. To achieve this, we want to recruit 30 healthy volunteers with different vitamin D levels, from low to normal. Then we will give half of them a large initial dose of vitamin D, and the other half a placebo pill. Everyone will then get a small vitamin D supplement for 6 weeks. We will measure their COP cell numbers every 3 weeks. We will look for changes in COP cells in those receiving different treatments and also with different starting vitamin D levels. There are no new medications or procedures being trialed in this study, so we expect it to be very safe.

Interventions

Experimental Group: Bolus dose of 50,000IU vitamin D once, followed by daily 1000IU Vitamin D supplementation for 6 weeks. 6 week supplements will be orally administered by the participant in tablet form. Bolus dose will be administered orally (tablet) in the presence of the study doctor. Supplements will be provided to the participants to self administer daily. Adherence to supplement regimen will be assessed at subsequent visits verbally.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

55 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

Age > 55yo Both male and females Independent in Activities of Daily Living (ADL) (Barthel > 60%) Vitamin D levels 0-70nmol/L Normal Bone Mineral Density (BMD) (>-1 SD)

Exclusion criteria

Current smoker High Body Mass Index (>30) Diabetes Hematopoietic / Hematological diseases Current or prior use of drugs that could interfere with bone mass (ie Glucocorticoids, anti-resorptive drugs, Hormone Replacement Therapy, Teriparatide) History of recent fracture in the last 3 months History of bone tumours Aortic valve calcification by auscultation or previous history HyperPTH (>6.8pmol/L)

Outcome results