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

Sponsor

Northwestern University (Other)

Overall Status

Completed

CT.gov ID

NCT00882505

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

4.2

Patients Per Site Per Month

Study Details

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	N/A

Study Design

Study Type:

Interventional

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 :

Apr 1, 2009

Actual Primary Completion Date :

Aug 1, 2010

Actual Study Completion Date :

Aug 1, 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.

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

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 47 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Apr 16, 2009

Last Update Posted:

Dec 2, 2021

Last Verified:

Nov 1, 2021

Additional relevant MeSH terms:

Vitamin D Deficiency

Vitamin D

Study Results

No Results Posted as of Dec 2, 2021