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Community-dwelling SeniorsPhase 2ZDPTNCT01017354

Zurich Disability Prevention Trial

A Phase 2 study testing Hidroferol® (ES) and ViDe3 (CH) in people with Community-dwelling Seniors and History of a Fall in the Previous 12 Months, run by University of Zurich at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 70 years and older
What is being tested?
Hidroferol® (ES) and ViDe3 (CH)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteSwitzerland
Study dates
Jan 2010to Dec 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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)
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  • 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)

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • University Hospital Zurich, Centre on Aging and Mobility

    Zurich, Canton of Zurich, 8091

Other trials in Switzerland

About this study

Official title: Monthly Vitamin D to Improve Vitamin D Status and Maintain Function in Pre-frail Older Individuals Living at Home

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.

Read the 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.

Being tested
Hidroferol® (ES), ViDe3 (CH)
Keywords
vitamin D, function, falls, 25-hydroxyvitamin D, disability

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hidroferol® (ES)Drug

    24000 IU vitamin D3 orally and once per month plus 300 mcg 25(OH)D orally and once per month

  • ViDe3 (CH)Dietary supplement

    60000 vitamin D3 orally and once per month

  • ViDe3 (CH)Dietary supplement

    24000 Vitamin D3 orally and once per month

Study groups in NCT01017354
Study groupRoleWhat they receive
High-dose vitamin D3Experimentalmonthly high-dose vitamin D3 supplement dose (60'000 IU/month, equivalent to 2000 IU daily)
Receives: Dietary Supplement: ViDe3 (CH)
standard vitamin D + 25(OH)DExperimentalstandard 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)
Receives: Drug: Hidroferol® (ES)
standard vitamin DActive comparatorstandard vitamin D3 supplement dose (24'000 IU/month, equivalent to 800 IU daily)
Receives: Dietary Supplement: ViDe3 (CH)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. functional decline (proportion of individuals with functional decline based on binary repeated measure assessment across 4 lower extremity tests)

    Measured: 6 and 12 months

  2. 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

    Measured: 6 and 12 months

Secondary outcomes (16)

  1. Safety at baseline, 2 weeks, 6 months, 12 months • Serum calcium adjusted for albumin • Serum creatinine • Urinary calcium/creatinine ratio

    Measured: 2 weeks, 6 months, 12 months

  2. Balance/Gait while walking combined with a cognitive task

    Measured: 12 months

  3. Short Physical Performance Test Battery

    Measured: 6 months, 12 months

  4. Timed 4 m walk

    Measured: 6 months, 12 months

  5. Musculoskeletal pain assessed with the McGill pain map

    Measured: 6 months and 12 months

  6. systolic and diastolic blood pressure, heart rate

    Measured: 6 month and 12 months

  7. Rate of falls, all, injurious falls (diary, monthly phone calls, and hotline)

    Measured: 12 months

  8. grip strength

    Measured: 6 months and 12 months

  9. Bone density at the spine and hip, whole body

    Measured: 6 months and 12 months

  10. incident vertebral fractures (iDXA morphometry)

    Measured: 12 months

  11. muscle mass, incident sarcopenia

    Measured: 6 and 12 months

  12. Health care utilization: in collaboration with insurance companies for outpatient and inpatient health care costs.

    Measured: 12 months

  13. Quality of life (SF 12 / EuroQuol)

    Measured: 6 months and 12 months

  14. Rate of hospital admission (fall-related injury, infections, other)

    Measured: 12 months

  15. Serum N-telopeptides and other markers of bone remodeling

    Measured: 6 months and 12 months

  16. Upper and lower respiratory tract infections, any infections, infections that lead to inpatient care

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2009 (estimated)
  2. Study startJan 2010
  3. Primary completionNov 2011
  4. Study completionDec 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01017354
Sponsor's protocol ID
KEK39/09
Other IDs
2009DR2248
Acronym
ZDPT
Status last verified
Aug 2015
First submitted
19 Nov 2009
Last updated
24 Aug 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Braendle K, Egli A, Bischoff-Ferrari H, Freystaetter G. Does living alone influence fall risk among Swiss older adults aged 60+? A pooled observational analysis of three RCTs on fall prevention. BMJ Open. 2024 May 20;14(5):e081413. doi: 10.1136/bmjopen-2023-081413.

    PubMed 38772577

  • Bischoff-Ferrari HA, Dawson-Hughes B, Orav EJ, Staehelin HB, Meyer OW, Theiler R, Dick W, Willett WC, Egli A. Monthly High-Dose Vitamin D Treatment for the Prevention of Functional Decline: A Randomized Clinical Trial. JAMA Intern Med. 2016 Feb;176(2):175-83. doi: 10.1001/jamainternmed.2015.7148.

    PubMed 26747333

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Hidroferol® (ES) and ViDe3 (CH) in people with Community-dwelling Seniors and History of a Fall in the Previous 12 Months, run by University of Zurich at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01017354, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2015.

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