To determine whether taking low doses of daily folic acid and vitamin B12 capsules for 2 years can improve bone health in coeliac disease patients

A double-blind, randomised, placebo controlled trial to investigate the effect of combined folic acid (400 µg) and vitamin B12 (10 µg) supplementation for 2 years on bone mineral density within coeliac disease patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN18076645

Enrollment

115

Registered

2012-10-11

Start date

2011-08-01

Completion date

Unknown

Last updated

2017-09-04

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

Conditions

Coeliac disease Digestive System Coeliac disease

Interventions

Intervention arm: Folic acid (400µg) and vitamin B12 (10µg) combined in a single capsule for 2 years Placebo: a single placebo capsule for 2 years

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Coeliac disease patients diagnosed by endoscope and over the age of 18 years

Exclusion criteria

Exclusion criteria: 1. Pregnancy 2. Current (or recent past) B-vitamin supplementation 3. Treatment with medication known to interfere with B-vitamin metabolism 4. Liver or kidney problems 5. Other gastrointestinal conditions

Design outcomes

Primary

Measure	Time frame
Bone mineral density (BMD) measured by dual energy X-ray absorptiometry	—

Secondary

Measure	Time frame
No secondary outcome measures	—

Countries

United Kingdom

Outcome results

None listed

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