Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Vitamin supplementation for six months will normalize biochemical markers, general well-being and gastrointestinal symptoms in adults with longstanding coeliac disease
Ethics approval
Approved by the Linkoping University Ethics Committee, Linkoping, Sweden on 19/05/2004, reference number: 44/04
Study design
Randomised, double-blind, parallel, placebo-controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Quality of life
Patient information sheet
Condition
Adult coeliac disease under dietary treatment
Intervention
A daily dose of TrioBe® (800 ug folic acid, 500 ug cyanocobalamin, 3 mg pyridoxine) versus placebo for six months
Intervention type
Supplement
Phase
Not Specified
Drug names
Vitamin supplements
Primary outcome measures
To determine if plasma total homocysteine, a marker of vitamin deficiency, could be normalized by six months of vitamin supplementation
Secondary outcome measures
To determine if psychological general well-being or gastrointestinal symptoms could be normalized by six months of vitamin supplementation
Overall trial start date
15/12/2003
Overall trial end date
28/11/2005
Reason abandoned
Eligibility
Participant inclusion criteria
1. Men and women aged 45-64 yrs with a biopsy-proven coeliac disease treated for at least 8 years and in proven remission
2. Declaration of keeping a strict gluten free diet
3. Written informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
65
Participant exclusion criteria
1. Concomitant serious disease
2. Hypersensitivity to B-vitamins
3. Positive coeliac disease serology
4. Unable to comply with protocol
5. Previous small intestinal resection
6. Vitamin supplementation during last three months
7. Concomitant phenobarbital, phenytoin, methotrexate and/or trimethoprim
Recruitment start date
15/12/2003
Recruitment end date
28/11/2005
Locations
Countries of recruitment
Sweden
Trial participating centre
NSÖ stab
Norrköping
S-601 82
Sweden
Sponsor information
Organisation
Recip AB (Sweden)
Sponsor details
7 Lagervägen
Haninge
S-136 50
Sweden
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Recip AB
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