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Health Benefits of a Vitamin D Supplementation Program in Alcoholism In Dutch: Vitamine toediening ter verbetering van de gezondheid bij vitamine D gebrek door alcoholgebruik


- candidate number15265
- NTR NumberNTR4114
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-aug-2013
- Secondary IDsSlingedael Korsakovcentrum, Rotterdam MEC-2012-273 (METC ErasmusMC), NL40553.078.12; EudraCt: 2012-002207-17 NL 20120502 CTA
- Public TitleHealth Benefits of a Vitamin D Supplementation Program in Alcoholism In Dutch: Vitamine toediening ter verbetering van de gezondheid bij vitamine D gebrek door alcoholgebruik
- Scientific TitleHealth Benefits of a Vitamin D Supplementation Program in Alcoholism
- ACRONYMVIDIO
- hypothesisVIDIO: Vitamin D Intensive Outreach includes a cholecalciferol loading dose, if applicable, and subsequent bimonthly high-dose cholecalciferol through an outreach approach of the Street Doctor Service in Rotterdam. CAU: Care As Usual includes daily prescriptions 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. We hypothesise that vitamin D supplementation may be more effective on vitamin D levels and muscle performance when given through VIDIO, rather than CAU depending upon medication prescriptions and medication compliance of the participants.
- Healt Condition(s) or Problem(s) studiedVitamin D deficiency, Myopathy
- Inclusion criteriaInclusion criteria are having a history of alcohol use and currently living in Rotterdam and vicinity.
- Exclusion criteriaExclusion criteria are knee surgery, first year after hip surgery, pregnancy/lactating or trying to conceive, already having vitamin D prescriptions for treatment of osteoporosis or hypovitaminosis 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 [15]: hypercalcaemia, renal failure (glomerular filtration rate <30 mL/min per 1,73m2), history of sarcoidosis, lymphomas, hyperparathyroidism, nephrolithiasis/calciuria, and soya or peanut allergy.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2013
- planned closingdate1-okt-2017
- Target number of participants200
- InterventionsAfter receiving the baseline laboratory results, an independent Doctorís Assistant allocates participants to one of the two vitamin D supplementation strategies (VIDIO and CAU). Participants with vitamin D deficiencies of <50 nmol/L serum 25-hydroxyvitamin D (25(OH)D) are randomly allocated to one of two different strategies (VIDIO and CAU) of vitamin D supplementation. VIDIO: Vitamin D Intensive Outreach includes a cholecalciferol loading dose, if applicable, and subsequent bimonthly high-dose cholecalciferol through an outreach approach of the Street Doctor Service in Rotterdam. CAU: Care As Usual includes daily prescriptions 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.
- Primary outcomePrimary outcome measures are serum 25(OH)vitamin D concentrations.
- Secondary outcomeSecondary outcome measures are maximal voluntary muscle strength of the participantsí dominant quadriceps muscle, the participantsí gait and balance abilities, and a health-related quality of life evaluation.
- TimepointsBaseline, 6 months, 12 months.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES J.W. Wijnia
- CONTACT for SCIENTIFIC QUERIES J.W. Wijnia
- Sponsor/Initiator Lelie Zorggroep
- Funding
(Source(s) of Monetary or Material Support)
Lelie Zorggroep
- Publications
- Brief summaryBackground: Decreased bioavailability of vitamins may be due to inadequate dietary sources, lower intestinal absorption and/or liver dysfunction. Muscular weakness and wasting is frequently found in chronic alcoholism and might be related to severe vitamin D hypovitaminosis.
Objective: To evaluate the effect of vitamin D supplementation in alcoholic myopathy through intensive outreach in 12 months follow-up.
Design, Setting and Participants: Participants are community-dwelling adults with a history of alcohol use and who are at risk of multiple vitamin deficiencies. Participants with vitamin D deficiencies of <50 nmol/L serum 25-hydroxyvitamin D (25(OH)D) are randomly allocated to one of two different strategies of vitamin D supplementation. The Vitamin D Intensive Outreach (VIDIO) program includes a cholecalciferol loading dose, if applicable, and subsequent bimonthly high-dose cholecalciferol through an outreach approach of the Street Doctor Service in Rotterdam, the Netherlands. Care As Usual (CAU) includes daily prescriptions of cholecalciferol 800 IU, available in combination with calcium carbonate, and depending on medication compliance of the participants.
Intervention: 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. Outcome measures: Primary outcomes are serum 25(OH)D concentrations. Secondary outcomes include the participantsí quadriceps maximal voluntary contractions, gait and balance abilities, results of cognitive screening, and a health-related quality of life evaluation. Prevalences of vitamin D and B1 deficiencies will be described.
Discussion: Mediating variables of vitamin D status are identified by assessing baseline characteristics, liver function and other laboratory findings, help-seeking behaviour, social support, and service engagement. Comparison between the two strategies of vitamin D therapy and serum 25(OH)D levels provides insight in the effectiveness of the intervention. Progress in muscle strength in the VIDIO intervention reflects an effect of vitamin D. Possible associations between results of cognitive screening and vitamin D or B1 deficiencies are discussed.
- Main changes (audit trail)
- RECORD13-aug-2013 - 16-sep-2013


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