|- candidate number||6110|
|- NTR Number||NTR1915|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||17-jul-2009|
|- Secondary IDs||26165 |
|- Public Title||Cholecalciferol in elderly with osteoarthritis of the hip.|
|- Scientific Title||The effect of high dose cholecalciferol orally on serum of vitamin D in elderly with osteoarthritis of the hip (Het effect van een hoge dosis vitamine D3 op het serum vitamine D in ouderen met coxartrose).|
|- ACRONYM||Cholecalciferol in elderly with osteoarthritis of the hip|
|- hypothesis||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.|
|- Healt Condition(s) or Problem(s) studied||Osteoarthritis, Vitamin D deficiency, Total hip replacement, Cholecalciferol|
|- 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.
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-nov-2009|
|- planned closingdate||1-nov-2010|
|- Target number of participants||80|
|- Interventions||150,000 or 300,000 IU cholecalciferol. |
|- 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.
|- Timepoints||On day 3, 5, 14 and after 6 weeks and 3 months.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||MD J. Alsma|
|- CONTACT for SCIENTIFIC QUERIES||Dr. P. Pilot|
|- Sponsor/Initiator |
(Source(s) of Monetary or Material Support)
|- Brief 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.
To study the effect of high dose oral cholecalciferol suppletion on serum 25-OHD in elderly with coxarthrosis.
A randomised double-blinded controlled clinical trial.
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.
|- Main changes (audit trail)|
|- RECORD||17-jul-2009 - 10-okt-2009|