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Comparison of 25-hydroxy Vitamin D Level in Caucasian Women Receiving Vitamin D Supplementation and Not Receiving Supplementation: a Randomized Controlled Trial.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00882505
Recruitment Status : Completed
First Posted : April 16, 2009
Last Update Posted : September 17, 2012
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Vitamin D Deficiency Dietary Supplement: vitamin D Other: Placebo

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : April 2009
Primary Completion Date : August 2010
Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Vitamin D supplement
Receive vitamin D supplements.
Dietary Supplement: vitamin D
Subject will receive vitamin d supplements
Placebo Comparator: Placebo
Receive placebo pills
Other: Placebo
Subject will receive a placebo.
No Intervention: Tanning bed user
Regular tanning bed users will be assessed for their vitamin D levels.

Outcome Measures

Primary Outcome Measures :
  1. 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 ]
  2. 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 Measures :
  1. The secondary outcome measures include evaluation of changes in other laboratory parameters associated with change in vitamin D level. [ Time Frame: 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 47 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
Contacts and Locations

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): NCT00882505

United States, Illinois
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Principal Investigator: Murad Alam, MD Northwestern University
More Information

Responsible Party: Murad Alam, Professor in Dermatology, Otolaryngology- Head and Neck Surgery, and Surgery-Organ Transplantation, Northwestern University
ClinicalTrials.gov Identifier: NCT00882505     History of Changes
Other Study ID Numbers: STU8461
First Posted: April 16, 2009    Key Record Dates
Last Update Posted: September 17, 2012
Last Verified: September 2012

Additional relevant MeSH terms:
Vitamin D Deficiency
Deficiency Diseases
Nutrition Disorders
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents