Vitamin supplementation in adult coeliac disease patients
| ISRCTN | ISRCTN42241118 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42241118 |
| Secondary identifying numbers | N/A |
- Submission date
- 16/03/2006
- Registration date
- 21/04/2006
- Last edited
- 11/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Claes Hallert
Scientific
Scientific
NSÖ stab
Vrinnevisjukhuset
Norrköping
S-601 82
Sweden
Study information
| Study design | Randomised, double-blind, parallel, placebo-controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Quality of life |
| 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 | 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 study start date | 15/12/2003 |
| Completion date | 28/11/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Sweden
Study participating centre
NSÖ stab
Norrköping
S-601 82
Sweden
S-601 82
Sweden
Sponsor information
Recip AB (Sweden)
Industry
Industry
7 Lagervägen
Haninge
S-136 50
Sweden
| Website | http://www.recip.se |
|---|---|
"ROR" |
https://ror.org/01apnjb23 |
Funders
Funder type
Industry
Recip AB
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 15/04/2009 | 11/01/2021 | Yes | No |
Editorial Notes
11/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
