ISRCTN ISRCTN38158659
DOI https://doi.org/10.1186/ISRCTN38158659
Secondary identifying numbers VitD2011-1
Submission date
02/04/2012
Registration date
27/04/2012
Last edited
19/09/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Severely obese people tend to score poorly on tests of physical function and are at increased risk of dying prematurely. Roughly two thirds of severely obese people have low vitamin D levels. We wish to determine if vitamin D supplementation can improve physical function in people with both severe obesity and a low vitamin D level.

Who can participate?
You can participate if you are aged between 18 and 65 years and if you have severe obesity (a body mass index greater than 40 kg/m2).

What does the study involve?
We will measure how long it takes you to walk 500 metres, at a moderately intense pace. If you have a low vitamin D level and you are willing to take a vitamin D supplement we will supply you with tablets containing vitamin D and calcium which you will be expected to take twice daily for 12 weeks. If your vitamin D level is not low or if you do not want to take a vitamin D supplement we would still like to measure how long it takes you to walk 500 metres after 12 weeks of no vitamin D supplementation. This will allow us compare the effects of vitamin D supplementation to the effects of no supplementation. Other ways that we will measure physical function will include timing how long it takes you to rise from a chair five times without using your hands and how long it you to walk 3 metres starting from and finishing in a seated position.

What are the possible benefits and risks of participating?
Less than 1% of people who take a vitamin D supplement will develop high calcium levels in their blood or urine. Less than 0.1% of people who take a vitamin D supplement will experience gastrointestinal symptoms (vomiting, diarrhoea, constipation) or a skin rash. Vitamin D supplements can decrease your risk of falling or of suffering a broken bone. Some studies show that vitamin D supplements may decrease the risk of diabetes and certain cancers.

Where is the study run from?
We will conduct this trial in St Columcille’s Hospital (Ireland).

When is the study starting and how long is it expected to run for?
The study ran from August 2011 to April 2013.

Who is funding the study?
St Columcille’s Hospital (Ireland).

Who is the main contact?
Dr Tomás Ahern
cuthbertmuldoon@gmail.com

Contact information

Prof Donal O'Shea
Scientific

Department of Endocrinology
St Columcille's Hospital
Loughlinstown
Dublin
4
Ireland

Study information

Study designSingle-centre prospective parallel-arm interventional study
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleVitamin D supplementation in the obese: a pilot study
Study objectivesVitamin D supplementation improves physical function in the severely obese
Ethics approval(s)St Vincent's Healthcare Group Ethics and Medical Research Committee, 11/07/2011, ref: Ahern July 11
Health condition(s) or problem(s) studiedSevere obesity, vitamin D deficiency
InterventionParticipants are allocated to the vitamin D supplementation (Caltrate®) arm if their serum 25-hydroxyvitamin D concentration is less than 50 nmol/L AND if they are willing to commence vitamin D supplementation. Participants are allocated to the no-treatment parallel arm if their serum 25-hydroxyvitamin D concentration is greater than 50 nmol/L OR if they are unwilling to commence vitamin D supplementation.

All participants allocated to the treatment arm will receive a 12-week supply of Caltrate® (containing 600 mg of calcium and 400 units of vitamin D per tablet) and be expected to take one tablet twice daily. Participants in the parallel, no-treatment arm will be expected to not take a calcium and vitamin D supplement.
Intervention typeSupplement
Primary outcome measureThe change in the time taken to walk 500 m at a moderately intense pace measured at 6 weeks before treatment, 0 weeks before treatment and 12 weeks after treatment
Secondary outcome measuresChange in the:
1. Time taken to complete an Up And Go Test (UAG, timed 3 metre walk starting from and finishing in a seated position)
2. Time taken to rise from a chair five times
3. Ability to complete tests of standing balance
4. Grip strength
5. Scores on quality of life questionnaires (SF-36, EQ-5D, ESS)
6. Number of peripheral blood mononuclear cell subsets
7. Serum hormone, bone turnover marker and cytokine concentrations
8. Blood pressure
9. Weight
10. Physical activity level

Measured at 6 weeks before treatment, 0 weeks before treatment and 12 weeks after treatment.
Overall study start date01/08/2011
Completion date01/04/2013

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit65 Years
SexBoth
Target number of participants60
Key inclusion criteria1. Aged between 18 and 65 years
2. Body mass index is greater than 40 kg/m2
Key exclusion criteria1. Known hypersensitivity to the active substances or any of the excipients of Caltrate®
2. Known hypersensitivity to soya or to peanut
3. Stage 4 or Stage 5 chronic kidney disease (eGFR < 30 ml/min/1.78m2)
4. Nephrolithiasis
5. Hypercalcaemia (serum calcium concentration > 2.6 mmol/L)
6. Pregnancy
7. Lactation
8. Psychotic mental illness
9. Inability to understand the participant information or to give informed consent
10. Any clinically significant chronic disease that might, in the opinion of the investigator, interfere with the evaluations or preclude completion of the trial (e.g., severe chronic lung disease, terminal illness)
11. Participation in a clinical trial during the 12 weeks prior to study entry (i.e., prior to screening visit)
Date of first enrolment01/08/2011
Date of final enrolment01/04/2013

Locations

Countries of recruitment

  • Ireland

Study participating centre

Department of Endocrinology
Dublin
4
Ireland

Sponsor information

St Vincent's University Hospital (Ireland)
Hospital/treatment centre

Obesity Research Group
Education and Research Centre
Elm Park
Dublin
4
Ireland

Website http://www.stvincents.ie/
ROR logo "ROR" https://ror.org/029tkqm80

Funders

Funder type

Hospital/treatment centre

St Columcille's Hospital (Ireland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan