Studies of Vitamin D supplements on Calcium Metabolism in Sarcoidosis

A one year randomised, double-blind placebo-controlled trial to evaluate the effects of vitamin D supplementation on serum calcium, urine calcium, bone turnover and bone density in subjects with sarcoidosis and vitamin D insufficiency.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000364471

Enrollment

Registered

2007-07-09

Start date

2007-10-04

Completion date

2010-12-22

Last updated

2020-01-13

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 is a one year study designed to test whether vitamin D supplementation is safe and efficacious for patients with sarcoidosis and low vitamin D levels

Interventions

Weekly oral calciferol 50,000 International Units (IU) for four weeks, then monthly oral calciferol 50,000 International Units (IU) for 11 months.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Diagnosis of sarcoidosis

Exclusion criteria

Serum creatinine >0.15 mmol/L, nephrocalcinosis, hypercalcaemia (adjusted serum calcium >2.55 mmol/L), concurrent major systemic illness (except for sarcoidosis) including malignancy, established osteoporosis (Bone mineral density T score < -2.5 and a fragility fracture)

Outcome results