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-OMON37463
- 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- Withdrawn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, i.e. what is the time serum<br /><br>25-OHD is remains above 50nmol/liter after a single oral dose of<br /><br>cholecalciferol.<br /><br>- To determine changes in general well being measured by SF-12.<br /><br>- To determine whether there is relapse of patients from sufficient to<br /><br>insufficient or deficient</p><br>