Vitamin supplementation in adult coeliac disease patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN42241118

Enrollment

Registered

2006-04-21

Start date

2003-12-15

Completion date

Unknown

Last updated

2021-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult coeliac disease under dietary treatment Nutritional, Metabolic, Endocrine Coeliac disease

Interventions

A daily dose of TrioBe® (800 µg folic acid, 500 µg cyanocobalamin, 3 mg pyridoxine) versus placebo for six months

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
To determine if plasma total homocysteine, a marker of vitamin deficiency, could be normalized by six months of vitamin supplementation	—

Secondary

Measure	Time frame
To determine if psychological general well-being or gastrointestinal symptoms could be normalized by six months of vitamin supplementation	—

Countries

Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026