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

NCT ID: NCT00882505

Last Updated: 2021-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2010-08-31

Brief Summary

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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

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Conditions

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Vitamin D Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Vitamin D supplement

Receive vitamin D supplements.

Group Type EXPERIMENTAL

vitamin D

Intervention Type DIETARY_SUPPLEMENT

Subject will receive vitamin d supplements

Placebo

Receive placebo pills

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Subject will receive a placebo.

Tanning bed user

Regular tanning bed users will be assessed for their vitamin D levels.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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vitamin D

Subject will receive vitamin d supplements

Intervention Type DIETARY_SUPPLEMENT

Placebo

Subject will receive a placebo.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

47 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Murad Alam

Professor in Dermatology, Otolaryngology- Head and Neck Surgery, and Surgery-Organ Transplantation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Murad Alam, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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STU8461

Identifier Type: -

Identifier Source: org_study_id