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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.

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ClinicalTrials.gov Identifier: NCT00882505
Recruitment Status : Completed
First Posted : April 16, 2009
Last Update Posted : September 17, 2012
Sponsor:
Information provided by (Responsible Party):
Murad Alam, Northwestern University

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 Phase
Vitamin D Deficiency Dietary Supplement: vitamin D Other: Placebo Not Applicable

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
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

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

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.



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 ]


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

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


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

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
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Hydroxycholecalciferols
Calcifediol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents