The effect of high dose cholecalciferol orally on serum of vitamin D in elderly with osteoarthritis of the hip
- Conditions
- Vitamin D deficiency10013296
- Registration Number
- NL-OMON32592
- Lead Sponsor
- Reinier de Graaf Groep
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 80
1. Informed consent signed by patient
2. Male and female patients aged 70 years and older
3. Diagnoses of osteoarthritis of the hip.
4. Baseline level of serum 25-OHD <100 nmol/liter
5. For inclusion in the conservative treatment group: Patients having osteoarthritis of the hip, which will be treated conservative.
6. For inclusion in the operative group: Patients having disabling osteoarthritis of the hip and scheduled for elective total hip surgery.
1. Unwillingness to cooperate with the study procedures
2. History of an active malignancy
3. Quetelet index (QI=weight in (kilogram)/ squire length (meters)) >40
4. History of chronic kidney disease (glomerular filtration rate (GFR) <20ml/min, calculated with Cockcroft-Gault equations)
5. History of primary hyperparathyroidism
6. History of sarcoidosis
7. Serum calcium corrected for serum albumin above 2.65nmol/l
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The effect of different doses cholecalciferol on serum 25-OHD</p><br>
- Secondary Outcome Measures
Name Time Method <p>- To determine the effect of 150,000 vs 300,000 IU cholecalciferol on serum<br /><br>calcium and PTH on day 3, 5, 14 and after 6 weeks and 3 months<br /><br>- To determine the effect of surgery on the absorption of cholecalciferol<br /><br>- To determine the effect of surgery on serum calcium and PTH<br /><br>- To determine whether there is a wash-out period of the effect of<br /><br>cholecalciferol during 3 months of follow up<br /><br>- To determine changes in general well being measured by SF-12. </p><br>