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

ISRCTN	ISRCTN18076645
DOI	https://doi.org/10.1186/ISRCTN18076645
Secondary identifying numbers	N/A

Submission date: 09/08/2012
Registration date: 11/10/2012
Last edited: 09/08/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Prof Helene McNulty
Scientific

University of Ulster
School of Biomedical Sciences
Coleraine campus
Cromore Road
Coleraine
BT52 1SA
United Kingdom

Phone	+44 (0)28 70124583
Email	h.mcnulty@ulster.ac.uk

Study information

Study design	Two-year double-blind randomised placebo controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please contact clarke-m3@email.ulster.ac.uk to request a patient information sheet
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
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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
Primary outcome measure	Bone mineral density (BMD) measured by dual energy X-ray absorptiometry
Secondary outcome measures	No secondary outcome measures
Overall study start date	18/06/2011
Completion date	29/05/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	115 participants
Key inclusion criteria	Coeliac disease patients diagnosed by endoscope and over the age of 18 years
Key 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
Date of first enrolment	01/08/2011
Date of final enrolment	01/05/2012

Locations

Countries of recruitment

Northern Ireland
United Kingdom

Study participating centre

University of Ulster

Coleraine
BT52 1SA
United Kingdom

Sponsor information

University of Ulster (UK)
Not defined

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

Website	http://www.ulster.ac.uk/
"ROR"	https://ror.org/01yp9g959

Funders

Funder type

Government

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

No information available

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)

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	01/08/2015		Yes	No

Editorial Notes

09/08/2017: Publication reference added.