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

Not Applicable

Completed

• Conditions: Vitamin D Deficiency
• Interventions: Dietary Supplement: vitamin D; Other: Placebo

• Registration Number: NCT00882505
• Lead Sponsor: Northwestern University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-15
• Study First Submitted QC: 2009-04-15
• Study First Posted: 2009-04-16
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-30
• Last Update Posted: 2021-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 67

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D supplement	vitamin D	Receive vitamin D supplements.
Placebo	Placebo	Receive placebo pills

Primary Outcome Measures

Name	Time	Method
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
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 Outcome Measures

Name	Time	Method
The secondary outcome measures include evaluation of changes in other laboratory parameters associated with change in vitamin D level.	3 months

Trial Locations

Locations (1)

Northwestern University Feinberg School of Medicine, Department of Dermatology; 🇺🇸 Chicago, Illinois, United States