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Alternative Treatments of Vitamin D Deficiency

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ClinicalTrials.gov Identifier: NCT01512537
Recruitment Status : Completed
First Posted : January 19, 2012
Last Update Posted : January 19, 2012
Sponsor:
Information provided by (Responsible Party):
Morten Bogh, Lund University

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

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Radiation: Narrowband UVB Dietary Supplement: Vitamin D and calcium Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Comparison of UVB and Vitamin D Supplementation in Treatment of Vitamin D Deficiency
Study Start Date : February 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Vitamin D (nmol/l). [ Time Frame: Week 0 ]
    Vitamin D was measured in a bloodsample to determine baseline status.

  2. 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.

  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.


Secondary Outcome Measures :
  1. Parathyroid hormone (pmol/l). [ Time Frame: Week 0, 3 and 6. ]
    To investigate whether parathyrodiea hormone changes during the study.

  2. Albumin (g/l). [ Time Frame: Week 0, 3 and 6. ]
    To investigate whether albumin changes during the study.

  3. Calcium (mmol/l) [ Time Frame: Week 0, 3 and 6. ]
    To investigate whether calcium changes during the study.

  4. Hemoglobin A 1c (percentage HbA1c of total hemoglobin). [ Time Frame: Week 0, 3 and 6. ]
    To investigate whether HbA1c changes during the study.



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Ages Eligible for Study:   15 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01512537


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

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Responsible Party: Morten Bogh, Principal Investigator, Lund University
ClinicalTrials.gov Identifier: NCT01512537     History of Changes
Other Study ID Numbers: 2009/687
First Posted: January 19, 2012    Key Record Dates
Last Update Posted: January 19, 2012
Last Verified: January 2012
Keywords provided by Morten Bogh, Lund University:
Vitamin D
UVB
Vitamin D supplementation
Additional relevant MeSH terms:
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Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Ergocalciferols
Vitamins
Calcium
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents