Condition category
Digestive System
Date applied
09/08/2012
Date assigned
11/10/2012
Last edited
08/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims:
B-vitamins, in particular folic acid and vitamin B12, may have a role in protecting bone health. Coeliac disease patients have a higher risk of both poor bone health and low B-vitamin levels. For this reason, we aim to investigate whether supplementing coeliac patients with folic acid and vitamin B12 for a 2 year time period can improve their bone health.

Who can participate?
Coeliac patients, diagnosed by endoscopy and over the age of 18.

What does the study involve?
Participants will be randomly assigned to one of two treatment groups, the placebo group (where participants take a daily placebo capsule) or the B-vitamin group (where you take a daily capsule containing folic acid and vitamin B12). The B-vitamin containing capsule and the placebo containing capsule look exactly the same so participants will not know what treatment you are assigned to. Participants will take a daily capsule for the 2 year study duration. Participants will also be invited to attend 3 appointments, one at the beginning of the 2 years, one after 1 year (i.e. half way through the study) and one at the end of the 2 year study. Each appointment will take approximately 1 hour and will involve an interview section (where participants will be asked questions about your diet, lifestyle and medical history), a measurements section (where participants height, weight, waist and hip measurements will be taken) and a blood sample (taking no more than 30mls of blood). Additionally, participants will have a DXA bone scan done at the first appointment and at the last appointment. DXA bone scans use low levels of X-rays to determine the bone mineral content, they are painless and take about 10 minutes to complete.

What are the possible benefits and risks of participating?
Any abnormal blood results and all DXA results will be sent to participants' GPs for follow-up. Participants taking the B-vitamin containing capsule, may show an improvement in bone mineral density. There are no negative side effects expected as a result of taking the daily capsule. There is the usual the risk of bruising accompanies every blood sample, however a fully trained phlebotomist will perform all the blood sampling and every effort will be made to minimise the risk of bruising. The DXA scan involves the use of small amounts of X-rays and is considered to pose a very low risk to you.

Where is the study run from?
The study is primarily run from the University of Ulster, Coleraine. Coeliac patients were recruited through Altnagelvin Hospital and Causeway Hospital.

When is the study starting and how long is it expected to run for?
The recruitment of study participants started in August 2011 and continued for 10 months. As a result, participants will finish the 2 year study duration at staggered times. All study appointments are expected to be complete by June 2014.

Who is funding the study?
NICHE (Northern Ireland Centre for Food and Health), the Western Trust Discretionary Research Fund of the WHSCT (Western Health and Social Care Trust) and DEL (Department of Education and Learning).

Who is the main contact?
Michelle Clarke
clarke-m3@email.ulster.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Helene McNulty

ORCID ID

Contact details

University of Ulster
School of Biomedical Sciences
Coleraine campus
Cromore Road
Coleraine
BT52 1SA
United Kingdom
+44 (0)28 70124583
h.mcnulty@ulster.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

Acronym

Study hypothesis

It is hypothesised that the coeliac patients supplemented with combined folic acid and vitamin B12 for a 2 year period will show an improvement in bone mineral density (and thereby bone health) compared to those coeliac disease patients taking the placebo capsule.

Ethics approval

1. Office for Research Ethics Committees in Northern Ireland (ORECNI), 10/05/2011
2. Western and Northern Health and Social Care Trusts, 18/05/2011 and 17/06/2011

Study design

Two-year double-blind randomised placebo controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please contact clarke-m3@email.ulster.ac.uk to request a patient information sheet

Condition

Coeliac disease

Intervention

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

Intervention type

Supplement

Phase

Not Applicable

Drug names

Folid acid, Vitamin B12

Primary outcome measures

Bone mineral density (BMD) measured by dual energy X-ray absorptiometry

Secondary outcome measures

No secondary outcome measures

Overall trial start date

18/06/2011

Overall trial end date

29/05/2015

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

115 participants

Participant 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

Recruitment start date

01/08/2011

Recruitment end date

01/05/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Ulster
Coleraine
BT52 1SA
United Kingdom

Sponsor information

Organisation

University of Ulster (UK)

Sponsor details

c/o Mr Nick Curry
Shore Road
Newtonabbey
Country Antrim
Antrim
BT37 0QB
United Kingdom

Sponsor type

Not defined

Website

http://www.ulster.ac.uk/

Funders

Funder type

Government

Funder name

Northern Ireland Centre for Food and Health (NICHE) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Western Trust Discretionary Research Fund of the WHSCT (Western Health and Social Care Trust) and DEL (Department of Education and Learning; PhD studentship) (UK)

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