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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR1915 |
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Date of registration:
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17/07/2009 |
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Primary sponsor: |
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Public title:
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Cholecalciferol in elderly with osteoarthritis of the hip.
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Scientific title:
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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). - Cholecalciferol in elderly with osteoarthritis of the hip |
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Date of first enrolment:
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1/11/2009 |
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Target sample size:
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80 |
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Recruitment status: |
pending |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1915 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: Double; Control: Active; Group: Parallel; Type: 2 or more arms, randomized
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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J.
Alsma |
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Address:
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Dept internal medicine RdGG Delft, Dept internal medicine RdGG Delft
Delft
The Netherlands |
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Telephone:
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+31 15 2603257 |
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Email:
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Alsma@rdgg.nl |
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Affiliation:
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Name:
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P.
Pilot |
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Address:
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Reinier de Graaf Gasthuis Delft
Department of Orthopaedics
PO box 5011
2600 GA
Delft
The Netherlands |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Osteoarthritis, Vitamin D deficiency, Total hip replacement, Cholecalciferol
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Intervention(s)
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150,000 or 300,000 IU cholecalciferol.
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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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.
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Source(s) of Monetary Support
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