Alternative Treatments of Vitamin D Deficiency

January 15, 2012 updated by: Morten Bogh, Lund University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Malmoe, Sweden, 205 02
        • Department of Dermatology, Lund University Malmoe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: UVB
UVB exposed group
Radiation: Narrowband UVB
UVB 3 times a week
Other Names:
  • NB-UVB
Active Comparator: Oral vitamin D tablet
Vitamin D supplementation
Dietary supplement: Vitamin D and calcium
1 daily tablet of 1600 IU vitamin D3 and 1000 mg calcium
Other Names:
  • Vitamin D supplementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vitamin D (nmol/l).
Time Frame: Week 0
Vitamin D was measured in a bloodsample to determine baseline status.
Week 0
Vitamin D (nmol/l)
Time Frame: Week 3
Vitamin D was measured in a bloodsample to follow the change from baseline in vitamin D level at week 3.
Week 3
Vitamin D
Time Frame: Week 6
Vitamin D was measured in a bloodsample to follow the change from baseline in vitamin D level at week 6.
Week 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parathyroid hormone (pmol/l).
Time Frame: Week 0, 3 and 6.
To investigate whether parathyrodiea hormone changes during the study.
Week 0, 3 and 6.
Albumin (g/l).
Time Frame: Week 0, 3 and 6.
To investigate whether albumin changes during the study.
Week 0, 3 and 6.
Calcium (mmol/l)
Time Frame: Week 0, 3 and 6.
To investigate whether calcium changes during the study.
Week 0, 3 and 6.
Hemoglobin A 1c (percentage HbA1c of total hemoglobin).
Time Frame: Week 0, 3 and 6.
To investigate whether HbA1c changes during the study.
Week 0, 3 and 6.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lund University

Investigators

  • Study Chair: Åke Svensson, Assoc. Prof., MD, PhD, Department of Dermatology, Lund University, Malmoe

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

December 22, 2011

First Submitted That Met QC Criteria

January 15, 2012

First Posted (Estimate)

January 19, 2012

Study Record Updates

Last Update Posted (Estimate)

January 19, 2012

Last Update Submitted That Met QC Criteria

January 15, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009/687

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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