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

Vitamin D Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00882505
• Other study ID #: STU8461
• Status: Completed
• Phase: N/A
• Start date: April 2009
• Est. completion date: August 2010

Study information

• Verified date: November 2021
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 47 Years

Eligibility

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

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Dietary Supplement:
• vitamin D
Subject will receive vitamin d supplements

Other:
• Placebo
Subject will receive a placebo.

Locations

Country	Name	City	State
United States	Northwestern University Feinberg School of Medicine, Department of Dermatology	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		3 months
Primary	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.		3 months
Secondary	The secondary outcome measures include evaluation of changes in other laboratory parameters associated with change in vitamin D level.		3 months