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

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ClinicalTrials.gov Identifier: NCT00322166
Recruitment Status : Completed
First Posted : May 5, 2006
Last Update Posted : October 21, 2009
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Accidental Falls Other: Sunlight Other: Sunlight and calcium Other: control

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Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (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
Study Start Date : July 2006
Primary Completion Date : November 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Falls [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Vit D [ Time Frame: 1 year ]
  2. Fractures [ Time Frame: 1 year ]
  3. Geriatric Depression [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: May 5, 2006    Key Record Dates
Last Update Posted: October 21, 2009
Last Verified: October 2009

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

Additional relevant MeSH terms:
Vitamins
Vitamin D
Calcium, Dietary
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents