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The FREEDOM Study: a Randomised Controlled Trial of Sunlight and Calcium in Older People

This study has been completed.
Sponsor:
Information provided by:
University of Sydney
ClinicalTrials.gov Identifier:
NCT00322166
First received: May 4, 2006
Last updated: October 20, 2009
Last verified: October 2009
History of Changes
  Purpose

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.


Condition Intervention
Accidental Falls
 Other: Sunlight
Other: Sunlight and calcium
Other: control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Randomised Controlled Trial of Sunlight and Calcium Supplementation to Reduce Vitamin D Deficiency and Falls in Older People in Residential Care

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sydney:

Primary Outcome Measures:
  • Falls [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Vit D [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Fractures [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Geriatric Depression [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: July 2006
Study Completion Date: December 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group A, Sunlight
Participants in this arm are required to sit in the sun most days of the week for 15 minutes
 Other: Sunlight
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.
Active Comparator: Group B, sunlight and calcium
Participants in this group receive sunlight and a calcium supplement
 Other: Sunlight and calcium
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.
No Intervention: Group C
Control group
 Other: control
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.

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  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • History of skin cancer in last three years
  • Taking vitamin D or calcium supplements
  • Not ambulant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00322166

Locations
Australia, New South Wales
Royal North Shore Hospital
Sydney, New South Wales, Australia, 2065
Sponsors and Collaborators
University of Sydney
Investigators
Principal Investigator: Philip Sambrook, MD University of Sydney
  More Information

No publications provided by University of Sydney

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Prof Philip Sambrook, University of Sydney
ClinicalTrials.gov Identifier: NCT00322166     History of Changes
Other Study ID Numbers: 402639, 0512-240M
Study First Received: May 4, 2006
Last Updated: October 20, 2009
Health Authority: Australia: National Health and Medical Research Council

Keywords provided by University of Sydney:
accidental falls
vitamin D
parathyroid hormone
osteoporosis

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Calcium, Dietary
Vitamin D
 Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on June 17, 2013