A study to compare the effectiveness and safety of an oral low dose and megadose of cholecalciferol treatment in participants with vitamin D deficiency - a real-life comparison pilot study.

A study to compare the effectiveness and safety of an oral low dose and a megadose vitamin D treatment regimens - a real-life comparison pilot study.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000338460

Enrollment

Registered

2007-06-26

Start date

2007-03-19

Completion date

Unknown

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 study will compare the effectiveness and safety of an oral low dose and a megadose vitamin D treatment regimen - it will be a real-life dose comparison study. This intervention study will have an active control group. The intervention will be oral 50,000 IU cholecalciferol daily for 10 days and then weekly for 3 months. The active comparator will be lower dose oral 1000 IU cholecalciferol tablets at a dose of four per day for one month and then one a day for 3 months. The outcome will be the numbers of subjects in each group achieving an optimal serum vitamin D level at 3 months. Safety measures will also be studied.

Interventions

The intervention will be oral 50,000 IU cholecalciferol daily for 10 days and then weekly for 3 months.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

Serum 25(0H) concentration < 50 nmol/L and ability to consent to trial participation.

Exclusion criteria

Inability to either give informed consent or complete the three month study, primary or tertiary hyperparathyroidism or other causes of hypercalcaemia.

Outcome results