|
ISRCTN
|
ISRCTN42241118
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Vitamin supplementation in adult coeliac disease patients
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
N/A
|
|
Study hypothesis
|
Vitamin supplementation for six months will normalize biochemical markers, general well-being and gastrointestinal symptoms in adults with longstanding coeliac disease
|
|
Lay summary
|
|
|
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
|
|
Countries of recruitment
|
Sweden
|
|
Disease/condition/study domain
|
Adult coeliac disease under dietary treatment
|
|
Participants - 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
|
|
Participants - 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
|
|
Anticipated start date
|
15/12/2003
|
|
Anticipated end date
|
28/11/2005
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
65
|
|
Interventions
|
A daily dose of TrioBe® (800 ug folic acid, 500 ug cyanocobalamin, 3 mg pyridoxine) versus placebo for six months
|
|
Primary outcome measure(s)
|
To determine if plasma total homocysteine, a marker of vitamin deficiency, could be normalized by six months of vitamin supplementation
|
|
Secondary outcome measure(s)
|
To determine if psychological general well-being or gastrointestinal symptoms could be normalized by six months of vitamin supplementation
|
|
Sources of funding
|
Recip AB
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Prof
Claes
Hallert
|
|
Address
|
NSÖ stab
Vrinnevisjukhuset
|
|
City/town
|
Norrköping
|
|
Zip/Postcode
|
S-601 82
|
|
Country
|
Sweden
|
|
Sponsor
|
Recip AB (Sweden)
|
|
Address
|
7 Lagervägen
|
|
City/town
|
Haninge
|
|
Zip/Postcode
|
S-136 50
|
|
Country
|
Sweden
|
|
Sponsor website:
|
http://www.recip.se
|
|
Date applied
|
16/03/2006
|
|
Last edited
|
21/04/2006
|
|
Date ISRCTN assigned
|
21/04/2006
|
