Cholecalciferol in elderly with osteoarthritis of the hip.

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).

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27613

Enrollment

Registered

2009-07-17

Start date

2009-11-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

vitamin D, deficiency, total hip, cholecalciferol, osteoarthritis

Interventions

150,000 or 300,000 IU cholecalciferol.

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Contacts

Public ContactJ. Alsma

Dept internal medicine RdGG Delft

Alsma@rdgg.nl+31 15 2603257

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)