Does vitamin D improve bone health?

ISRCTN	ISRCTN62971200
DOI	https://doi.org/10.1186/ISRCTN62971200
EudraCT/CTIS number	2011-005228-17
Secondary identifying numbers	FORSS-232891

Submission date: 24/03/2013
Registration date: 14/06/2013
Last edited: 03/03/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Background and study aims
The incidence of bone fractures later in life is higher amongst women who have previously suffered from anorexia (eating disorder). The purpose of this trial is to investigate whether treatment with vitamin D, in either a standard or a high dose, can improve bone health in female patients with anorexia. The study will provide information on vitamin D metabolism in anorexia and on what doses are to be recommended in that disease.

Who can participate?
Female patients with anorexia and female blood donors, who are over 18 years, can participate in this study.

What does the study involve?
The study is a randomized, double-blind prospective , two center trial . The study will compare daily vitamin D3 supplementation with either a standard dose (400 IUs (n = 50 ) or a higher dose with a target S-25 (OH) vitamin D concentration 75-125 nmol/L (n=50). The patients (100) are followed for two years with bloodsamples , anthropometric measurements and DEXA. As comparison a group of female blood donors (100) are used.

What are the possible benefits and risks of participating?
Possible benefits: an increased understanding of bone disease in anorexia and of suitable doses of vitamin D in anorexia.
Possible risks: a small risk of side effects from vitamin D and calcium exists (constipation, nausea, abdominal pain, diarrhea and an even smaller risk of kidney stones).

Where is the study run from?
The study is run from Kalmar and Linköping, Sweden.

When is the study starting and how long is it expected to run for?
The study started in February 2013 and is expected to continue until February 2016.

Who is funding the study?
The study is funded by FORSS: Medical Council of Southeast Sweden.

Who is the main contact?
Dr Pär Wanby
par.wanby@ltkalmar.se

Contact information

Dr Pär Wanby
Scientific

Sec of EWndocrinology
Dept of Internal Medicine
County Hospital of Kalmar
Kalmar
SE 392 47 Kalmar
Sweden

Phone	+46 480 448204
Email	PerW@LTKalmar.se

Study information

Study design	Randomised controlled study.
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet.
Scientific title	Does treatment with vitamin D lower the incidence of osteoporosis in female patients with anorexia?
Study hypothesis	Treatment with high doses of vitamin D lowers the incidence of osteoporosis in patients with anorexia nervosa.
Ethics approval(s)	Dnr 2012/145-31 (EPN Linköping, Sweden 2012-05-23)
Condition	1. Anorexia nervosa (weight fobia, BMI < 17.5, lack of menstration for 3 consecutive months). 2. Osteoporosis
Intervention	100 female patients with anorexia nervosa are randomised to two groups. Bone markers and bone density are followed throughout the study. 1. 1 tablet of: Calcium carbonate 500 mg + Colecalciferol 400 IE p os daily 2. 1 tablet of: Calcium carbonate 500 mg + Colecalciferol 400 IE p os daily + Colecalciferol (oil drops 80 IE/drop) p os.daily. The initial dose of the vitamin D oil drops is 1600 IE. This dose is adjusted from the patients plasma concentration of vitamin D (goal: 90 - 125 nmol/L). The total dose of vitamin D is not to exceed 4000 IE/day. Each patient is on either of these two treatments for two years and is also monitored for this period of time. Control group: blood donors
Intervention type	Other
Primary outcome measure	Bone density: C-teleopeptide of collagen type I (s-CTX) and osteocalcin 25-OH vitamin D3 is measured at baseline, 1, 2, 3, 6, 12, 18 and 24 months. A dual energy X-ray absorptiometry (DXA) is performed at baseline, after 12 and 24 months. Pituitary hormones and after 24 months. Bone markers (C-teleopeptide of collagen type I, osteocaline) are measured at baseline and at 6, 12, 18 and 24 months.
Secondary outcome measures	Omega-3 fatty acids, insulin resistance and pituitary hormones. Glucose and insulin are measured at baseline and 18 months.
Overall study start date	01/02/2013
Overall study end date	31/12/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	100 patients with anorexia + 100 controll subjects (blood doners).
Participant inclusion criteria	1. 100 female (age above 18 years) patients that fullfill the criteria of anorexia nervosa, are willing to participate in the study and do not fullfill the exclusion criteria. 2. 100 female blood doners with an age above 18, and willing to participate in the study.
Participant exclusion criteria	1. Treatment with litium, bisfosfonates, antiepileptics or cortison 2. Allergy towards any substance that are part of the vitamin D or calcium medication of the study or allergy towards soja, peanats 3. Hyperkalcemia, a history of kidney stones or a vitamin D plasma concentration (25-OH-D3 ) >90 nmol/L or an estimated GFR < 40 ml/min 4. Pregnancy
Recruitment start date	01/02/2013
Recruitment end date	01/02/2016

Locations

Countries of recruitment

Sweden

Study participating centre

Sec of EWndocrinology

Kalmar
SE 392 47 Kalmar
Sweden

Sponsor information

Kalmar County Hospital (Sweden)
Hospital/treatment centre

c/o Pär Wanby
Section of Endocrinology
Dept of Internal Medicine
Kalmar
SE 391 85
Sweden

Phone	+46 (0) 48 044 8204
Email	PerW@LTKalmar.se
"ROR"	https://ror.org/04g3stk86

Funders

Funder type

Research council

FORSS: Medical Research Council of Southeast Sweden (Sweden)

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

Editorial Notes

02/02/2017: The overall trial end date has been updated from 01/02/2016 to 31/12/2017