Condition category
Nutritional, Metabolic, Endocrine
Date applied
16/03/2006
Date assigned
21/04/2006
Last edited
21/04/2006
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

Prof Claes Hallert

ORCID ID

Contact details

NSÖ stab
Vrinnevisjukhuset
Norrköping
S-601 82
Sweden

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

http://www.recip.se

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

Publication citations

Additional files

Editorial Notes