Condition category
Nutritional, Metabolic, Endocrine
Date applied
01/06/2007
Date assigned
19/09/2007
Last edited
19/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.recip.se/

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

Publication citations

Additional files

Editorial Notes