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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.

This study has been completed.
Information provided by (Responsible Party):
Murad Alam, Northwestern University Identifier:
First received: April 15, 2009
Last updated: September 14, 2012
Last verified: September 2012
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 Intervention
Vitamin D Deficiency
Dietary Supplement: vitamin D
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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.

Resource links provided by NLM:

Further study details as provided by Northwestern University:

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

Enrollment: 67
Study Start Date: April 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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
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Please refer to this study by its identifier: 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 Identifier: NCT00882505     History of Changes
Other Study ID Numbers: STU8461
Study First Received: April 15, 2009
Last Updated: September 14, 2012

Additional relevant MeSH terms:
Vitamin D Deficiency
Deficiency Diseases
Nutrition Disorders
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents processed this record on May 25, 2017