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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 14, 2014