Back to results

Alternative Treatments of Vitamin D Deficiency

Primary Purpose

Vitamin D Deficiency

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Narrowband UVB

Vitamin D and calcium

About this trial

This is an interventional basic science trial for Vitamin D Deficiency focused on measuring Vitamin D, UVB, Vitamin D supplementation

Eligibility Criteria

15 Years - 70 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Department of Dermatology, Lund University Malmoe

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

UVB

Oral vitamin D tablet

Arm Description

UVB exposed group

Vitamin D supplementation

Outcomes

Primary Outcome Measures

Vitamin D (nmol/l).

Vitamin D was measured in a bloodsample to determine baseline status.

Vitamin D (nmol/l)

Vitamin D was measured in a bloodsample to follow the change from baseline in vitamin D level at week 3.

Vitamin D

Vitamin D was measured in a bloodsample to follow the change from baseline in vitamin D level at week 6.

Secondary Outcome Measures

Parathyroid hormone (pmol/l).

To investigate whether parathyrodiea hormone changes during the study.

Albumin (g/l).

To investigate whether albumin changes during the study.

Calcium (mmol/l)

To investigate whether calcium changes during the study.

Hemoglobin A 1c (percentage HbA1c of total hemoglobin).

To investigate whether HbA1c changes during the study.

Full Information

NCT ID

NCT01512537

First Posted

December 22, 2011

Last Updated

January 15, 2012

Sponsor

Lund University

1. Study Identification

Unique Protocol Identification Number

NCT01512537

Brief Title

Alternative Treatments of Vitamin D Deficiency

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Completed

Study Start Date

February 2010 (undefined)

Primary Completion Date

April 2011 (Actual)

Study Completion Date

November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Lund University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vitamin D Deficiency

Keywords

Vitamin D, UVB, Vitamin D supplementation

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

UVB

Arm Type

Active Comparator

Arm Description

UVB exposed group

Arm Title

Oral vitamin D tablet

Arm Type

Active Comparator

Arm Description

Vitamin D supplementation

Intervention Type

Radiation

Intervention Name(s)

Narrowband UVB

Other Intervention Name(s)

NB-UVB

Intervention Description

UVB 3 times a week

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin D and calcium

Other Intervention Name(s)

Vitamin D supplementation

Intervention Description

1 daily tablet of 1600 IU vitamin D3 and 1000 mg calcium

Primary Outcome Measure Information:

Title

Vitamin D (nmol/l).

Description

Vitamin D was measured in a bloodsample to determine baseline status.

Time Frame

Week 0

Title

Vitamin D (nmol/l)

Description

Vitamin D was measured in a bloodsample to follow the change from baseline in vitamin D level at week 3.

Time Frame

Week 3

Title

Vitamin D

Description

Vitamin D was measured in a bloodsample to follow the change from baseline in vitamin D level at week 6.

Time Frame

Week 6

Secondary Outcome Measure Information:

Title

Parathyroid hormone (pmol/l).

Description

To investigate whether parathyrodiea hormone changes during the study.

Time Frame

Week 0, 3 and 6.

Title

Albumin (g/l).

Description

To investigate whether albumin changes during the study.

Time Frame

Week 0, 3 and 6.

Title

Calcium (mmol/l)

Description

To investigate whether calcium changes during the study.

Time Frame

Week 0, 3 and 6.

Title

Hemoglobin A 1c (percentage HbA1c of total hemoglobin).

Description

To investigate whether HbA1c changes during the study.

Time Frame

Week 0, 3 and 6.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Åke Svensson, Assoc. Prof., MD, PhD

Organizational Affiliation

Department of Dermatology, Lund University, Malmoe

Official's Role

Study Chair

Facility Information:

Facility Name

Department of Dermatology, Lund University Malmoe

City

Malmoe

ZIP/Postal Code

205 02

Country

Sweden

12. IPD Sharing Statement

Learn more about this trial

Alternative Treatments of Vitamin D Deficiency

We'll reach out to this number within 24 hrs