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.
Sponsor:
Information provided by (Responsible Party):
Murad Alam, Northwestern University
ClinicalTrials.gov Identifier:
NCT00882505
First received: April 15, 2009
Last updated: September 14, 2012
Last verified: September 2012
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 47 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: April 15, 2009
Last Updated: September 14, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 27, 2014