NCT01512537

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2011

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 19, 2012

Completed
Last Updated

January 19, 2012

Status Verified

January 1, 2012

Enrollment Period

1.2 years

First QC Date

December 22, 2011

Last Update Submit

January 15, 2012

Conditions

Keywords

Vitamin DUVBVitamin D supplementation

Outcome Measures

Primary Outcomes (3)

  • Vitamin D (nmol/l).

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

    Week 0

  • 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

  • Vitamin D

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

    Week 6

Secondary Outcomes (4)

  • Parathyroid hormone (pmol/l).

    Week 0, 3 and 6.

  • Albumin (g/l).

    Week 0, 3 and 6.

  • Calcium (mmol/l)

    Week 0, 3 and 6.

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

    Week 0, 3 and 6.

Study Arms (2)

UVB

ACTIVE COMPARATOR

UVB exposed group

Radiation: Narrowband UVB

Oral vitamin D tablet

ACTIVE COMPARATOR

Vitamin D supplementation

Dietary Supplement: Vitamin D and calcium

Interventions

UVB 3 times a week

Also known as: NB-UVB
UVB
Vitamin D and calciumDIETARY_SUPPLEMENT

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

Also known as: Vitamin D supplementation
Oral vitamin D tablet

Eligibility Criteria

Age15 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Vitamin D deficiency (\< 25 nmol/l)
  • Age 15 or above

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dermatology, Lund University Malmoe

Malmo, 205 02, Sweden

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Vitamin DCalcium

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsMetals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological Factors

Study Officials

  • Åke Svensson, Assoc. Prof., MD, PhD

    Department of Dermatology, Lund University, Malmoe

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 22, 2011

First Posted

January 19, 2012

Study Start

February 1, 2010

Primary Completion

April 1, 2011

Study Completion

November 1, 2011

Last Updated

January 19, 2012

Record last verified: 2012-01

Locations