NCT01017354

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 20, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

August 24, 2015

Status Verified

August 1, 2015

Enrollment Period

1.8 years

First QC Date

November 19, 2009

Last Update Submit

August 21, 2015

Conditions

Community-dwelling SeniorsHistory of a Fall in the Previous 12 Months

Keywords

vitamin Dfunctionfalls25-hydroxyvitamin Ddisability

Outcome Measures

Primary Outcomes (2)

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

    6 and 12 months

  • 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

    6 and 12 months

Secondary Outcomes (16)

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

    2 weeks, 6 months, 12 months

  • Balance/Gait while walking combined with a cognitive task

    12 months

  • Short Physical Performance Test Battery

    6 months, 12 months

  • Timed 4 m walk

    6 months, 12 months

  • Musculoskeletal pain assessed with the McGill pain map

    6 months and 12 months

  • +11 more secondary outcomes

Study Arms (3)

High-dose vitamin D3

EXPERIMENTAL

monthly high-dose vitamin D3 supplement dose (60'000 IU/month, equivalent to 2000 IU daily)

Dietary Supplement: ViDe3 (CH)

standard vitamin D + 25(OH)D

EXPERIMENTAL

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)

standard vitamin D

ACTIVE COMPARATOR

standard vitamin D3 supplement dose (24'000 IU/month, equivalent to 800 IU daily)

Dietary Supplement: ViDe3 (CH)

Interventions

Hidroferol® (ES)DRUG

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

standard vitamin D + 25(OH)D
ViDe3 (CH)DIETARY_SUPPLEMENT

60000 vitamin D3 orally and once per month

High-dose vitamin D3

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Centre on Aging and Mobility

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (2)

  • 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.

    PMID: 38772577DERIVED

  • 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.

    PMID: 26747333DERIVED

MeSH Terms

Interventions

Calcifediol

Intervention Hierarchy (Ancestors)

HydroxycholecalciferolsCholecalciferolCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Heike Bischoff Ferrari, MD, MPH

    University Hospital Zurich, Centre on Aging and Mobility

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2009

First Posted

November 20, 2009

Study Start

January 1, 2010

Primary Completion

November 1, 2011

Study Completion

December 1, 2011

Last Updated

August 24, 2015

Record last verified: 2015-08

Locations

CH(1)