The aims of this study are to observe the effectiveness of oral vitamin D supplementation on vitamin D status and muscle performance in vitamin D-deficient alcoholics during two different vitamin D treatment strategies (VIDIO and CAU).
ID
Source
Brief title
Condition
- Vitamin related disorders
- Muscle disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcomes are serum 25(OH)D concentrations.
Secondary outcome
Secondary outcomes include the participants* quadriceps maximal voluntary
contractions, gait and balance abilities, and a health-related quality of life
evaluation.
Background summary
Previous studies suggested that muscle weakness in alcoholics was not primarily
related to the patient's nutritional status or vitamin B deficiencies. Since
vitamin D hypovitaminosis is a well recognised cause of myopathy, the question
remains whether muscle weakness in alcoholism may be caused by vitamin D
deficiency.
Study objective
The aims of this study are to observe the effectiveness of oral vitamin D
supplementation on vitamin D status and muscle performance in vitamin
D-deficient alcoholics during two different vitamin D treatment strategies
(VIDIO and CAU).
Study design
This study is an open, two-arm randomised controlled trial.
Intervention
This study is a randomised two-arm trial of vitamin D supplementation with
Vitamin D Intensive Outreach (VIDIO) including cholecalciferol loading dose, if
applicable, and subsequent (bimonthly) high-dose cholecalciferol through an
outreach approach of the Street Doctor Service in Rotterdam, versus Care As
Usual (CAU) comprising daily prescription of cholecalciferol 800 IU, available
in combination with calcium carbonate. The VIDIO intervention is based upon
general principles to enhance medication compliance for successful treatment,
disease prevention, and health promotion, by means of a simple medication
regime in one-on-one patient contacts.
Study burden and risks
A total number of three blood samples are collected (total volume = 44•5 mL)
over one year. The questionnaires usually take around one and a half hour to
complete. Total three test sessions of muscle strength and balance testing are
of 20 minutes each. Although the dynamometer is padded, tenderness may occur
over the dynamometer placement sites especially after repeated trials. Except
in those with conditions causing hypersensitivity (primary hyperparathyroidism,
sarcoidosis, tuberculosis, or lymphoma) there is no evidence of adverse effects
with serum 25(OH)D concentrations <140 nmol/L, which require a total vitamin D
supply of 250 µg (10,000 IU) per day to attain.
Slinge 901
Rotterdam 3086 EZ
NL
Slinge 901
Rotterdam 3086 EZ
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria are having a history of alcohol abuse and currently living in Rotterdam and vicinity, and serum 25-hydroxyvitamin D concentration below 50 nmol/L at baseline.
Exclusion criteria
Exclusion criteria are a high risk or serious suspicion of Wernicke*s encephalopathy, knee surgery, first year after hip surgery, pregnancy/lactating or trying to conceive, already having vitamin D prescriptions for treatment of osteoporosis or hypo-vitaminosis D myopathy, inability to give informed consent because of mental incapacity, insufficient command of the Dutch language, and contraindications of Calci Chew D3 or cholecalciferol: hypercalcaemia, renal failure (glomerular filtration rate <30 mL/min per 1.73m2), history of tuberculosis, sarcoidosis, lymphomas, hyperparathyroidism, nephrolithiasis/calciuria, and soya or peanut allergy.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-002207-17-NL |
| CCMO | NL40553.078.12 |