Contact information
Type
Scientific
Primary contact
Dr Goran Toss
ORCID ID
Contact details
Department of Endocrinology
EM-kliniken
University Hospital
Linköping
S-58185
Sweden
+46 (0)13 222 000
Goran.Toss@lio.se
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CT06-MEGA-001
Study information
Scientific title
Acronym
MEGA
Study hypothesis
The treatment to be tried will result in recommended levels of serum 25-hydroxy-vitamin D.
Ethics approval
Ethics approval received from Regionala Etikprovningsnamnden i Linkoping, Sweden (one of six regional ethical boards in Sweden) on the 11th October 2006 (ref: Dnr M150-06 [EudraCT-nr: 2006-002595-17]).
Study design
A prospective randomised double-blind parallel group study evaluating efficacy and safety of a one year treatment.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Mild or moderate vitamin D deficiency
Intervention
Supplementation with either calcium and vitamin D or calcium alone. The subjects will be treated with two tablets per day for twelve months. The allocation of subjects to treatment, study product (vitamin D and calcium) or reference product (calcium), will be done by randomisation at start of the study.
Intervention type
Supplement
Phase
Not Specified
Drug names
Kalcipos®, vitamin D
Primary outcome measures
Serum levels of 25-hydroxyvitamin D, measured at baseline, 3, 6, 9 and 12 months.
Secondary outcome measures
1. Serum levels of parathyroid hormone and biochemical bone markers, measured at baseline, 6 and 12 months
2. Safety, measured at baseline, 3, 6, 9 and 12 months
Overall trial start date
05/01/2007
Overall trial end date
31/12/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Men and women 55 to 85 years of age
2. Mild or moderate vitamin D insufficiency (serum 25-hydroxy-vitamin D 10-70 nmol/L)
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
56
Participant exclusion criteria
1. Subjects with severe vitamin D deficiency (serum 25-hydroxy-vitamin D below 10 nmol/L)
2. Suspected osteomalacia
3. Serious diseases or drug treatments that may interfere with study results
Recruitment start date
05/01/2007
Recruitment end date
31/12/2008
Locations
Countries of recruitment
Sweden
Trial participating centre
Department of Endocrinology
Linköping
S-58185
Sweden
Sponsor information
Organisation
Recip AB (Sweden)
Sponsor details
Lagervagen 7
Haninge
S-13650
Sweden
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Recip AB (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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