A randomised double-blind parallel-group study evaluating effcacy and safety on MEGA tablets compared to Kalcipos® tablets in adult subjects
| ISRCTN | ISRCTN72183044 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72183044 |
| Secondary identifying numbers | CT06-MEGA-001 |
- Submission date
- 01/06/2007
- Registration date
- 19/09/2007
- Last edited
- 19/09/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Goran Toss
Scientific
Scientific
Department of Endocrinology
EM-kliniken
University Hospital
Linköping
S-58185
Sweden
| Phone | +46 (0)13 222 000 |
|---|---|
| Goran.Toss@lio.se |
Study information
| 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 |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | |
| Study acronym | MEGA |
| Study objectives | The treatment to be tried will result in recommended levels of serum 25-hydroxy-vitamin D. |
| Ethics approval(s) | 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]). |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 05/01/2007 |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 56 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 05/01/2007 |
| Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Department of Endocrinology
Linköping
S-58185
Sweden
S-58185
Sweden
Sponsor information
Recip AB (Sweden)
Industry
Industry
Lagervagen 7
Haninge
S-13650
Sweden
| Website | http://www.recip.se/ |
|---|---|
"ROR" |
https://ror.org/01apnjb23 |
Funders
Funder type
Industry
Recip AB (Sweden)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
