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

Northwestern University67 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Vitamin D Deficiency

Interventions

vitamin DDIETARY_SUPPLEMENT

Subject will receive vitamin d supplements

PlaceboOTHER

Subject will receive a placebo.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 47 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, United States

Outcomes

Primary Outcomes

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 Outcomes

The secondary outcome measures include evaluation of changes in other laboratory parameters associated with change in vitamin D level.

Time frame: 3 months

Data from ClinicalTrials.gov

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