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

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

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

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

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

• 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

Contacts and Locations

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

More Information

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

Additional relevant MeSH terms:

Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Vitamin D; Vitamins; Micronutrients; Physiological Effects of Drugs; Bone Density Conservation Agents