Zurich Disability Prevention Trial

Launched by UNIVERSITY OF ZURICH · Nov 19, 2009

Keywords

ClinConnect Summary

We propose a double-blind, randomized controlled trial to test the effectiveness of a

1. Active I (n=70): monthly high-dose vitamin D3 supplement dose (60'000 IU/month, equivalent to 2000 IU daily),
2. Active II (n=70): or a monthly standard vitamin D3 supplement dose combined with 25(OH)D (24'000 IU/month, equivalent to 800 IU daily PLUS 300 mcg 25(OH)D, equivalent to 10 mcg per day)
3. Control (n=70): compared to a standard vitamin D3 supplement dose (24'000 IU/month, equivalent to 800 IU daily)

All individuals will be advised to consume calcium from natural food sources in a daily dose...

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • Age 70+
• • Fall in the last 12 months before screening (with or without a fracture)
• • Living at home (community-dwelling)
• • Men or women
• • Mobile with or without walking aid - have to be able to use public transportation to attend the clinical visits at the trial centre
• • Score of at least 27 at the screening Folstein Mini Mental test + normal clock test
• • Patient understands the study procedures, alternative treatments available and risks involved with the study, and voluntarily agrees to participate by giving a written informed consents.
• • Patient meets the entry minimal requirements based on routine clinical laboratory safety screening tests and the Folstein mini mental status (score 27+ required) performed at the Screening Visit.
• • Patient is willing to perform all study tests, attend all required office visits, and provide blood and urine samples.
• Exclusion criteria:
• • Serum calcium adjusted for albumin of \> 2.6 nmol/l
• • Pathologic fracture in the last year (except for fractures due to osteoporosis)
• • Chemo therapy / Radiation due to cancer in the last year
• • Treatment which has an effect on bone metabolism (e.g. bisphosphonate, PTH, calcitonin, chronic cortisone intake \> XYmg/day for more than XY month/years (except for inhalation and sporadic infiltration))
• • Oral vitamin D intake of more than 800 IU per day
• • Unwilling to stop calcium supplementation and vitamin D supplementation during the trial (maximal calcium supplement intake 250mg/d; no additional vitamin D supplementation)
• • Severe visual or hearing impairment
• • Unwilling or unable to take study medication
• • Diseases with a risk of recurrent falling (e.g. Parkinson's disease/syndrome, Hemiplegia after stroke, symptomatic stenosis of the spinal canal, polyneuropathy, epilepsy, recurring vertigo, recurring syncope)
• • BMI \>= 40
• • Estimated creatinine clearance \< 15 ml/min (estimated Creatinine Clearance Cockcroft and Gault)
• • Malabsorption syndrome (celiac diseases, inflammatory bowl disease)
• • Diseases that may enhance serum calcium: sarcoidosis, lymphoma, primary hyperparathyroidism
• • kidney stone in the last 10 years
• • Abnormal indices of calcium metabolism, uncontrolled hypocalcemia.
• • Patient heavily consumes alcohol containing products defined as greater than (\>) 3 drinks (beer, wine, or distilled spirits) of alcoholic beverages per day.
• • Patient is unlikely to adhere to the study procedures, to keep appointments, or is planning to relocate during the study.
• • Patients who are planning a stay in a "sunny" location (e.g. winter sun resort) for more than two months per year
• • Medication which has an effect on 25-hydroxyvitamin D level (e.g. certain anticonvulsants (e.g. Phenobarbital, Carbamazepin, Phenytoin))
• • M. Paget (Ostitis deformans)
• • inflammatory arthritis (e.g. rheumatoid arthritis, reiter syndrome, psoriasis arthritis)