Can treatment with vitamin D lower the incidence of osteoporosis (bone disease increasing the risk of fracture)?
- Conditions
- Osteoporosis in anorexia nervosaTherapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- EUCTR2011-005228-17-SE
- Lead Sponsor
- Kalmar County Council
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
Females (>=18 years) fullfilling the criteria of anorexia and willing to participate in the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Treatment with litium, bisfosfonates, antiepileptics, cortison, disease with a risk of developing hypercalcemia, hypercalciuria, kidneystones. A vitamin D conentration > 100 nmol/L or an estimated GFR < 40 ml/min.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine wether it is with vitamin D treament is possible to normalise bonemetabolism and density in female anorextic patients.;Secondary Objective: To study what doses of vitamin D is necessary in order to adequetly increase concentrations of vitamin D in female anorextic patients.;Primary end point(s): Vitamin D concentration;Timepoint(s) of evaluation of this end point: Baseline and every three months (every month during first three months)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Bonemarkers and bone density;Timepoint(s) of evaluation of this end point: Baseline, at 12 and 24 months (+ bonemarkers at 6 months).