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The effect of high dose cholecalciferol orally on serum of vitamin D 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 - cholecalciferol in elderly with osteoarthritis of the hip

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON32592
Enrollment
80
Registered
2010-04-09
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

Vitamin D deficiency

Interventions

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 gettin

Sponsors

Reinier de Graaf Groep
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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)

Design outcomes

Primary

MeasureTime frame
The effect of different doses cholecalciferol on serum 25-OHD—

Secondary

MeasureTime frame
- 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.—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)