Alternative Treatments of Vitamin D Deficiency

Vitamin D Deficiency Clinical Trial

Official title:

Comparison of UVB and Vitamin D Supplementation in Treatment of Vitamin D Deficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01512537
• Other study ID #: 2009/687
• Status: Completed
• Phase: N/A
• First received: December 22, 2011
• Last updated: January 15, 2012
• Start date: February 2010
• Est. completion date: November 2011

Study information

• Verified date: January 2012
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to compare the efficiency of UVB and vitamin D supplementation in treatment of vitamin D deficiency.

Description:

Patients with vitamin D deficiency were recruited and randomized into two groups, one exposed to UVB and the other receiving oral treatment with vitamin D supplementation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years to 70 Years

Eligibility

Inclusion Criteria:

• Vitamin D deficiency (< 25 nmol/l)

• Age 15 or above

Exclusion Criteria:

• Travel south of 45 degrees latitude during the trial.

• Ongoing treatment with vitamin D supplementation.

• Intake of light sensitive medicine, such as tetracyclins.

• Skin light eruptions

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Radiation:
• Narrowband UVB
UVB 3 times a week

Dietary Supplement:
• Vitamin D and calcium
1 daily tablet of 1600 IU vitamin D3 and 1000 mg calcium

Locations

Country	Name	City	State
Sweden	Department of Dermatology, Lund University Malmoe	Malmoe

Sponsors (1)

Lead Sponsor	Collaborator
Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vitamin D (nmol/l).	Vitamin D was measured in a bloodsample to determine baseline status.	Week 0	No
Primary	Vitamin D (nmol/l)	Vitamin D was measured in a bloodsample to follow the change from baseline in vitamin D level at week 3.	Week 3	No
Primary	Vitamin D	Vitamin D was measured in a bloodsample to follow the change from baseline in vitamin D level at week 6.	Week 6	No
Secondary	Parathyroid hormone (pmol/l).	To investigate whether parathyrodiea hormone changes during the study.	Week 0, 3 and 6.	No
Secondary	Albumin (g/l).	To investigate whether albumin changes during the study.	Week 0, 3 and 6.	No
Secondary	Calcium (mmol/l)	To investigate whether calcium changes during the study.	Week 0, 3 and 6.	No
Secondary	Hemoglobin A 1c (percentage HbA1c of total hemoglobin).	To investigate whether HbA1c changes during the study.	Week 0, 3 and 6.	No