A pilot study the effect of high dose oral cholecalciferol suppletion on serum 25-OHD in elderly with osteoarthritis of the hip.
ID
Source
Brief title
Condition
- Bone, calcium, magnesium and phosphorus metabolism disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The effect of different doses cholecalciferol on serum 25-OHD
Secondary outcome
- To determine the effect of 150,000 vs 300,000 IU cholecalciferol on serum
calcium and PTH on day 3, 5, 14 and after 6 weeks and 3 months
- To determine the effect of surgery on the absorption of cholecalciferol
- To determine the effect of surgery on serum calcium and PTH
- To determine whether there is a wash-out period of the effect of
cholecalciferol during 3 months of follow up
- To determine changes in general well being measured by SF-12.
Background summary
Vitamin D insufficiency and deficiency are becoming a worldwide problem. It is
associated with increased risk of falling, osteoporosis and increased risk of
fractures. Elderly are more at risk for vitamin D insufficiency and deficiency.
Several strategies for vitamin D suppletion are used, however a high loading
dose is hardly used.
Study objective
A pilot study the effect of high dose oral cholecalciferol suppletion on serum
25-OHD in elderly with osteoarthritis of the hip.
Study design
A randomised double-blinded controlled clinical pilot trial.
Intervention
Two groups of patients will be formed, one group of patients being treated
conservative, one group of patients who will be operated. Within both groups
the patients will be randomised between getting a single oral dose of either
150,000 IU or 300,000 IU cholecalciferol
Study burden and risks
A high loading dose is a potent way of raising serum 25-OHD. In theory, there
is a risk of vitamin D toxicity resulting in hypercalcaemia. Patients can be
allergic to one of the ingredients of cholecalciferol. Extra blood test form an
additional burden as well as extra visits to the clinic and filling in the
SF-12 forms.
reinier de graafweg 3-11
2625 AD Delft
Nederland
reinier de graafweg 3-11
2625 AD Delft
Nederland
Listed location countries
Age
Inclusion criteria
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.
Exclusion criteria
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
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-011301-16-NL |
| CCMO | NL30202.098.09 |