Condition category
Nutritional, Metabolic, Endocrine
Date applied
19/12/2005
Date assigned
19/12/2005
Last edited
24/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Ilse Wicherts

ORCID ID

Contact details

VU University Medical Center
EMGO - LASA
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
+31 (0)20 4449336
i.wicherts@vumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR350; METC 2003-202

Study information

Scientific title

Acronym

Study hypothesis

Supplementation of vitamin D3 (daily 800 IU or 3 monthly 100,000 IU) has the same effect on muscle complaints and weakness among non western immigrants as daily UV light exposure (sunlight).

Ethics approval

Received from local medical ethics committee

Study design

Multicentre randomised open label active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Vitamin D deficiency, Muscle weakness

Intervention

Time period: 6 months
1. Sunlight exposure: April until Sept
2. 3 monthly supplementation of vitamin D3 - 100,000 IU, VU University Medical Center
3. Daily supplementation of vitamin D3 - 800 IU, Lommerse Pharma

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Muscle strength and mobility (Takei TKK 5001, Hoggan MicroFEt, Chairtest). Measurement: baseline and after 3, 6 and 12 months
2. 25-OH Vitamin D, PTH: baseline and after 3, 6, 12 months
3. Phosphate, Alkaline phosphatase, Albumin, Creatinine, Glucose Hb, Ht: baseline and after 6 months

Secondary outcome measures

Sunlight exposure, diet, use of medicine intake, questionnaires: baseline and after 3, 6, 12 months.

Overall trial start date

15/03/2004

Overall trial end date

01/06/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. 25-OH Vitamin D <25 nmol/l
2. Age during study: 18-65 years
3. Non-western immigrants

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

210

Participant exclusion criteria

1. No complaints or symptoms
2. No diseases which are interfering with measurement (e.g. psychoses, arthritis of the knee or hip)

Recruitment start date

15/03/2004

Recruitment end date

01/06/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

VU University Medical Center
Amsterdam
1081 BT
Netherlands

Sponsor information

Organisation

VU University Medical Centre (Netherlands)

Sponsor details

EMGO-Institute and Department of Public and Occupational Health
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
emgo@vumc.nl

Sponsor type

Not defined

Website

Funders

Funder type

Research organisation

Funder name

Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

Alternative name(s)

Netherlands Organisation for Health Research and Development

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Netherlands

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes