Vitamin supplementation in adult coeliac disease patients

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Claes Hallert
Scientific

NSÖ stab
Vrinnevisjukhuset
Norrköping
S-601 82
Sweden

Primary study design	Interventional
Study design	Randomised, double-blind, parallel, placebo-controlled study
Secondary study design	Randomised controlled trial
Scientific title	Vitamin supplementation in adult coeliac disease patients
Study objectives	Vitamin supplementation for six months will normalize biochemical markers, general well-being and gastrointestinal symptoms in adults with longstanding coeliac disease
Ethics approval(s)	Approved by the Linkoping University Ethics Committee, Linkoping, Sweden on 19/05/2004, reference number: 44/04
Health condition(s) or problem(s) studied	Adult coeliac disease under dietary treatment
Intervention	A daily dose of TrioBe® (800 µg folic acid, 500 µg cyanocobalamin, 3 mg pyridoxine) versus placebo for six months
Intervention type	Supplement
Primary outcome measure(s)	To determine if plasma total homocysteine, a marker of vitamin deficiency, could be normalized by six months of vitamin supplementation
Key secondary outcome measure(s)	To determine if psychological general well-being or gastrointestinal symptoms could be normalized by six months of vitamin supplementation
Completion date	28/11/2005

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	65
Total final enrolment	65
Key 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
Key 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
Date of first enrolment	15/12/2003
Date of final enrolment	28/11/2005

NSÖ stab

Norrköping
S-601 82
Sweden

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	15/04/2009	11/01/2021	Yes	No

11/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.