Alternative Treatments of Vitamin D Deficiency

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Morten Bogh, Lund University
ClinicalTrials.gov Identifier:
NCT01512537
First received: December 22, 2011
Last updated: January 15, 2012
Last verified: January 2012
  Purpose

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


Condition Intervention
Vitamin D Deficiency
Radiation: Narrowband UVB
Dietary Supplement: Vitamin D and calcium

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Comparison of UVB and Vitamin D Supplementation in Treatment of Vitamin D Deficiency

Resource links provided by NLM:


Further study details as provided by Lund University:

Primary Outcome Measures:
  • Vitamin D (nmol/l). [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
    Vitamin D was measured in a bloodsample to determine baseline status.

  • Vitamin D (nmol/l) [ Time Frame: Week 3 ] [ Designated as safety issue: No ]
    Vitamin D was measured in a bloodsample to follow the change from baseline in vitamin D level at week 3.

  • Vitamin D [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    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). [ Time Frame: Week 0, 3 and 6. ] [ Designated as safety issue: No ]
    To investigate whether parathyrodiea hormone changes during the study.

  • Albumin (g/l). [ Time Frame: Week 0, 3 and 6. ] [ Designated as safety issue: No ]
    To investigate whether albumin changes during the study.

  • Calcium (mmol/l) [ Time Frame: Week 0, 3 and 6. ] [ Designated as safety issue: No ]
    To investigate whether calcium changes during the study.

  • Hemoglobin A 1c (percentage HbA1c of total hemoglobin). [ Time Frame: Week 0, 3 and 6. ] [ Designated as safety issue: No ]
    To investigate whether HbA1c changes during the study.


Enrollment: 32
Study Start Date: February 2010
Study Completion Date: November 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: UVB
UVB exposed group
Radiation: Narrowband UVB
UVB 3 times a week
Other Name: 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 Name: Vitamin D supplementation

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.

  Eligibility

Ages Eligible for Study:   15 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01512537

Locations
Sweden
Department of Dermatology, Lund University Malmoe
Malmoe, Sweden, 205 02
Sponsors and Collaborators
Lund University
Investigators
Study Chair: Åke Svensson, Assoc. Prof., MD, PhD Department of Dermatology, Lund University, Malmoe
  More Information

No publications provided

Responsible Party: Morten Bogh, Principal Investigator, Lund University
ClinicalTrials.gov Identifier: NCT01512537     History of Changes
Other Study ID Numbers: 2009/687
Study First Received: December 22, 2011
Last Updated: January 15, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Lund University:
Vitamin D
UVB
Vitamin D supplementation

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 27, 2014