Back to resultsComparison of 25-hydroxy Vitamin D Level in Caucasian Women Receiving Vitamin D Supplementation and Not Receiving Supplementation: a Randomized Controlled Trial.
Primary Purpose
Vitamin D Deficiency
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
vitamin D
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Vitamin D Deficiency
Eligibility Criteria
Inclusion Criteria:
- Premenopausal Caucasian women, ages 18-47
- Subjects in good health
- Tanning bed group: regular tanning bed user at least once a week for previous 10 weeks
Exclusion Criteria:
- Pregnancy and lactation
- Subjects with liver disease, renal disease, multiple myeloma, parathyroid disease, irritable bowel disease, celiac disease, cystic fibrosis and pancreatic disease
- Subjects with hypocholesterolemia and primary hyperparathyroidism
Subjects taking the following medications:
- Steroids
- Orlistat
- Lipid lowering medication: cholestyramine, statins
- Antiepileptic drugs: phenobarbital and phenytoin
- Currently on vitamin D supplements or using any medication contain vitamin D i.e. cod liver oil, topical calcipotriol or history of use within 1 month
- Rifampicin, isoniazid
- Ketoconazole
- Subjects currently on UV therapy
Sites / Locations
- Northwestern University Feinberg School of Medicine, Department of Dermatology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
No Intervention
Arm Label
Vitamin D supplement
Placebo
Tanning bed user
Arm Description
Receive vitamin D supplements.
Receive placebo pills
Regular tanning bed users will be assessed for their vitamin D levels.
Outcomes
Primary Outcome Measures
For the randomized controlled trial, the primary outcome measure is comparison of the change in vitamin D levels in the vitamin D supplementation group and the placebo group.
For the comparative study, the primary outcome measure is comparison of the vitamin D level for tanning bed users compared to the level for non-tanning bed users.
Secondary Outcome Measures
The secondary outcome measures include evaluation of changes in other laboratory parameters associated with change in vitamin D level.
Full Information
NCT ID
NCT00882505
First Posted
April 15, 2009
Last Updated
November 30, 2021
Sponsor
Northwestern University
1. Study Identification
Unique Protocol Identification Number
NCT00882505
Brief Title
Comparison of 25-hydroxy Vitamin D Level in Caucasian Women Receiving Vitamin D Supplementation and Not Receiving Supplementation: a Randomized Controlled Trial.
Official Title
Comparison of 25-hydroxy Vitamin D Level in Caucasian Women Receiving Vitamin D Supplementation and Not Receiving Supplementation: a Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to assess whether vitamin D supplements are sufficient to increase females who are deficient or borderline deficient in vitamin D levels to normal levels.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D supplement
Arm Type
Experimental
Arm Description
Receive vitamin D supplements.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Receive placebo pills
Arm Title
Tanning bed user
Arm Type
No Intervention
Arm Description
Regular tanning bed users will be assessed for their vitamin D levels.
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin D
Intervention Description
Subject will receive vitamin d supplements
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Subject will receive a placebo.
Primary Outcome Measure Information:
Title
For the randomized controlled trial, the primary outcome measure is comparison of the change in vitamin D levels in the vitamin D supplementation group and the placebo group.
Time Frame
3 months
Title
For the comparative study, the primary outcome measure is comparison of the vitamin D level for tanning bed users compared to the level for non-tanning bed users.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
The secondary outcome measures include evaluation of changes in other laboratory parameters associated with change in vitamin D level.
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
47 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Premenopausal Caucasian women, ages 18-47
Subjects in good health
Tanning bed group: regular tanning bed user at least once a week for previous 10 weeks
Exclusion Criteria:
Pregnancy and lactation
Subjects with liver disease, renal disease, multiple myeloma, parathyroid disease, irritable bowel disease, celiac disease, cystic fibrosis and pancreatic disease
Subjects with hypocholesterolemia and primary hyperparathyroidism
Subjects taking the following medications:
Steroids
Orlistat
Lipid lowering medication: cholestyramine, statins
Antiepileptic drugs: phenobarbital and phenytoin
Currently on vitamin D supplements or using any medication contain vitamin D i.e. cod liver oil, topical calcipotriol or history of use within 1 month
Rifampicin, isoniazid
Ketoconazole
Subjects currently on UV therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murad Alam, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University Feinberg School of Medicine, Department of Dermatology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparison of 25-hydroxy Vitamin D Level in Caucasian Women Receiving Vitamin D Supplementation and Not Receiving Supplementation: a Randomized Controlled Trial.
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