Zurich Disability Prevention Trial (ZDPT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01017354
First received: November 19, 2009
Last updated: December 22, 2011
Last verified: December 2011
  Purpose

This project was designed to optimizing vitamin D status in prefrail seniors age 70+ living at home and prevent their functional decline. We test 3 arms of monthly vitamin D supplementation. Intermittent dosing will improve adherence and simplify vitamin D supplementation.


Condition Intervention Phase
Community-dwelling Seniors
History of a Fall in the Previous 12 Months
Drug: Hidroferol® (ES)
Dietary Supplement: ViDe3 (CH)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Monthly Vitamin D to Improve Vitamin D Status and Maintain Function in Pre-frail Older Individuals Living at Home

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • functional decline (proportion of individuals with functional decline based on binary repeated measure assessment across 4 lower extremity tests) [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Improving 25-hydroxyvitamin D levels in late winter and late summer - Percent of individuals reaching desirable 25-hydroxyvitamin D levels of at least 75 nmol/l in late winter and in late summer [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety at baseline, 2 weeks, 6 months, 12 months • Serum calcium adjusted for albumin • Serum creatinine • Urinary calcium/creatinine ratio [ Time Frame: 2 weeks, 6 months, 12 months ] [ Designated as safety issue: Yes ]
  • Balance/Gait while walking combined with a cognitive task [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Short Physical Performance Test Battery [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]
  • Timed 4 m walk [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]
  • Musculoskeletal pain assessed with the McGill pain map [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
  • systolic and diastolic blood pressure, heart rate [ Time Frame: 6 month and 12 months ] [ Designated as safety issue: No ]
  • Rate of falls, all, injurious falls (diary, monthly phone calls, and hotline) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • grip strength [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
  • Bone density at the spine and hip, whole body [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
  • incident vertebral fractures (iDXA morphometry) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • muscle mass, incident sarcopenia [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Health care utilization: in collaboration with insurance companies for outpatient and inpatient health care costs. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Quality of life (SF 12 / EuroQuol) [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
  • Rate of hospital admission (fall-related injury, infections, other) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Serum N-telopeptides and other markers of bone remodeling [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
  • Upper and lower respiratory tract infections, any infections, infections that lead to inpatient care [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: January 2010
Study Completion Date: December 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High-dose vitamin D3
monthly high-dose vitamin D3 supplement dose (60'000 IU/month, equivalent to 2000 IU daily)
Dietary Supplement: ViDe3 (CH)
60000 vitamin D3 orally and once per month
Experimental: standard vitamin D + 25(OH)D
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)
Drug: Hidroferol® (ES)
24000 IU vitamin D3 orally and once per month plus 300 mcg 25(OH)D orally and once per month
Active Comparator: standard vitamin D
standard vitamin D3 supplement dose (24'000 IU/month, equivalent to 800 IU daily)
Dietary Supplement: ViDe3 (CH)
24000 Vitamin D3 orally and once per month

Detailed Description:

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 of 600-800 mgs a day, including milk products. Maximal intake of supplemental calcium is restricted to 250 mg per day.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 25 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 25+ 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01017354

Locations
Switzerland
University Hospital Zurich, Centre on Aging and Mobility
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Heike Bischoff Ferrari, MD, MPH University Hospital Zurich, Centre on Aging and Mobility
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01017354     History of Changes
Other Study ID Numbers: KEK39/09, 2009DR2248
Study First Received: November 19, 2009
Last Updated: December 22, 2011
Health Authority: Switzerland: Swissmedic

Keywords provided by University of Zurich:
vitamin D
function
falls
25-hydroxyvitamin D
disability

Additional relevant MeSH terms:
Calcifediol
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on April 17, 2014