NCT00322166

Brief Summary

The proposed study will determine the effect of a public health strategy (ie. increased sun light exposure and increased calcium intake) to reduce falls in older people in residential care using a randomised trial. The primary hypothesis of the trial is that increased appropriate sun light exposure will reduce falls, improve 25 hydroxy vitamin D (25OHD) levels and lower parathyroid hormone (PTH) levels. Secondary hypotheses are that the intervention will reduce accelerated bone turnover, reduce fractures, improve motor function and improve mood.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2006

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 5, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

October 21, 2009

Status Verified

October 1, 2009

Enrollment Period

2.3 years

First QC Date

May 4, 2006

Last Update Submit

October 20, 2009

Conditions

Accidental Falls

Keywords

accidental fallsvitamin Dparathyroid hormoneosteoporosis

Outcome Measures

Primary Outcomes (1)

  • Falls

    1 year

Secondary Outcomes (3)

  • Vit D

    1 year

  • Fractures

    1 year

  • Geriatric Depression

    1 year

Study Arms (3)

Group A, Sunlight

ACTIVE COMPARATOR

Participants in this arm are required to sit in the sun most days of the week for 15 minutes

Other: Sunlight

Group B, sunlight and calcium

ACTIVE COMPARATOR

Participants in this group receive sunlight and a calcium supplement

Other: Sunlight and calcium

Group C

NO INTERVENTION

Control group

Other: control

Interventions

SunlightOTHER

Subjects in the intervention groups will be asked to undergo exposure of approximately 15% of their body (ie the face, hands and arms) usually between 9.30am - 10am daily during the year, 5 days per week.

Group A, Sunlight
Sunlight and calciumOTHER

Subjects in the intervention groups will be asked to undergo exposure of approximately 15% of their body (ie the face, hands and arms) usually between 9.30am - 10am daily during the year, 5 days per week. In the calcium and sunlight arm, calcium supplements (Caltrate, 600mg elemental calcium, Whitehall) will be administered to the whole group via the Blister/ Webster packs.

Group B, sunlight and calcium
controlOTHER

Subjects in the control group will be provided with a brochure about vitamin D deficiency and how to treat it. They will receive their usual routine care and nutrition.

Group C

Eligibility Criteria

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

You may qualify if:

  • Aged 70 years or more
  • Ambulant
  • Likely to survive for more than 12 months, as assessed by the Implicit Review Tool employed in the FREE study
  • Not taking vitamin D or calcium supplements
  • No history of skin cancer in last three years

You may not qualify if:

  • History of skin cancer in last three years
  • Taking vitamin D or calcium supplements
  • Not ambulant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal North Shore Hospital

Sydney, New South Wales, 2065, Australia

Location

Related Publications (1)

  • Sambrook PN, Cameron ID, Chen JS, Cumming RG, Durvasula S, Herrmann M, Kok C, Lord SR, Macara M, March LM, Mason RS, Seibel MJ, Wilson N, Simpson JM. Does increased sunlight exposure work as a strategy to improve vitamin D status in the elderly: a cluster randomised controlled trial. Osteoporos Int. 2012 Feb;23(2):615-24. doi: 10.1007/s00198-011-1590-5. Epub 2011 Mar 3.

    PMID: 21369788DERIVED

MeSH Terms

Conditions

Osteoporosis

Interventions

SunlightCalcium

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

LightElectromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, NonionizingWeatherAtmosphereEnvironmentEcological and Environmental PhenomenaBiological PhenomenaMeteorological ConceptsEnvironment and Public HealthMetals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological Factors

Study Officials

  • Philip Sambrook, MD

    University of Sydney

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 4, 2006

First Posted

May 5, 2006

Study Start

July 1, 2006

Primary Completion

November 1, 2008

Study Completion

December 1, 2008

Last Updated

October 21, 2009

Record last verified: 2009-10

Locations

AU(1)