No registrations found.
ID
Source
Brief title
Health condition
vitamin D, deficiency, total hip, cholecalciferol, osteoarthritis
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine the effect of 150,000 vs 300,000 IU cholecalciferol on serum 25-OHD on day 3, 5, 14 and after 6 weeks and 3 months in patients undergoing major orthopaedic surgery or receiving conservative treatment.
Secondary outcome
1. 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;
2. To determine the effect of surgery on the absorption of cholecalciferol;
3. To determine the effect of surgery on serum calcium and PTH;
4. To determine whether there is a wash-out period of the effect of cholecalciferol during 3 months of follow up, i.e. what is the time serum 25-OHD is remains above 50nmol/liter after a single oral dose of cholecalciferol;
5. To determine changes in general well being measured by SF-12;
6. To determine whether there is relapse of patients from sufficient to insufficient or deficient.
Background summary
Rationale:
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.
Objective:
To study the effect of high dose oral cholecalciferol suppletion on serum 25-OHD in elderly with coxarthrosis.
Study design:
A randomised double-blinded controlled clinical trial.
Study population:
Patients with coxarthrosis aged 70 years and older.
Intervention (if applicable):
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.
Main study parameters/endpoints:
The effect of different doses cholecalciferol on serum 25-OHD.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
A high loading dose is a potent way of raising serum 25-OHD. In theory, there is a risk of vitamin D toxicity. Extra blood test form an additional burden as well as extra visits to the clinic.
Study objective
It is hypothesised that a loading dose of 150,000 IU cholecalciferol and of 300,000 IU are both effective in normalizing serum 25-OHD in insufficient en deficient individuals, but also in elevating serum 25-OHD in elderly with sufficient serum 25-OHD without toxicity, meaning that the lowest of both doses is preferred. It is not expected that elective hip surgery will influence cholecalciferol uptake.
Study design
On day 3, 5, 14 and after 6 weeks and 3 months.
Intervention
150,000 or 300,000 IU cholecalciferol.
J. Alsma
Dept internal medicine RdGG Delft
Delft
The Netherlands
+31 15 2603257
Alsma@rdgg.nl
J. Alsma
Dept internal medicine RdGG Delft
Delft
The Netherlands
+31 15 2603257
Alsma@rdgg.nl
Inclusion criteria
1. Informed consent signed by patient;
2. Male and female patients aged 70 years and older;
3. If female: of non child bearing potential;
4. Diagnoses of osteoarthritis of the hip;
5. Baseline level of serum 25-OHD <100 nmol/liter;
6. For inclusion in the conservative treatment group: Patients having coxarthrosis, which will be treated conservative;
7. For inclusion in the operative group: Patients having disabling coxarthrosis 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
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 |
|---|---|
| NTR-new | NL1805 |
| NTR-old | NTR1915 |
| Other | : 26165 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |