Contact information
Type
Scientific
Primary contact
Prof Adrian Grant
ORCID ID
Contact details
Health Services Research Unit
University of Aberdeen
Polwarth Building
Foresterhill
Aberdeen
AB9 2ZD
United Kingdom
+44 (0)1224 553908
a.grant@adn.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G9706483
Study information
Scientific title
Acronym
RECORD
Study hypothesis
1. Daily oral Vitamin D or Calcium, or the two in combination, given to people aged 70 or over who have recently been successfully treated for a fracture likely to be related to osteoporosis, will decrease the incidence of subsequent fractures.
2. The cost of any effective regimen will be less than those associated with the fracture prevented
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Condition
Primary care
Intervention
Daily oral Vitamin D/Calcium/Vitamin D and calcium in combination/placebo
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. New fractures,
2. Cost per avoided new fracture
3. Quality of life gain
Secondary outcome measures
Not provided at time of registration
Overall trial start date
18/11/1998
Overall trial end date
30/04/2004
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged 70 years or over (irrespective of sex)
2. Recent first proximal femoral or other appendicular fracture sustained in a fall or clinical vertebral fracture
3. Attending fracture clinic or hospital in-patient
4. Resident in UK
5. Able to comply with protocol (eg Mini-mental Score greater than 7)
6. Gives consent
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
5250
Participant exclusion criteria
1. Multiple or high energy transfer injury
2. Inability to walk prior to presenting fracture without the support of others
3. Suffering from known malignant disease
4. Contraindication to Calcium or Vitamin D
5. Current or recent treatment with more than 200iu daily of Vitamin D, Calcium, Fluoride, Diphosphonate or Calcitonin
Recruitment start date
18/11/1998
Recruitment end date
30/04/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Health Services Research Unit
Aberdeen
AB9 2ZD
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2005 results in: http://www.ncbi.nlm.nih.gov/pubemd/15885294
2. 2007 results in: http://www.ncbi.nlm.nih.gov/pubmed/17702768
3. 2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/19617604
4. 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24401173
Publication citations
-
Results
Avenell A, Cook JA, Maclennan GS, Macpherson GC, Vitamin D supplementation to prevent infections: a sub-study of a randomised placebo-controlled trial in older people (RECORD trial, ISRCTN 51647438)., Age Ageing, 2007, 36, 5, 574-577, doi: 10.1093/ageing/afm091.
-
Results
Avenell A, Cook JA, MacLennan GS, McPherson GC, , Vitamin D supplementation and type 2 diabetes: a substudy of a randomised placebo-controlled trial in older people (RECORD trial, ISRCTN 51647438)., Age Ageing, 2009, 38, 5, 606-609, doi: 10.1093/ageing/afp109.
-
Results
MacLennan G, McDonald A, McPherson G, Treweek S, Avenell A, , Advance telephone calls ahead of reminder questionnaires increase response rate in non-responders compared to questionnaire reminders only: The RECORD phone trial., Trials, 2014, 15, 13, doi: 10.1186/1745-6215-15-13.