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

Study Overview
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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.

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

Conditions
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Vitamin D Deficiency

Intervention / Treatment
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* Dietary Supplement: vitamin D
* Other: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 47 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D supplement<br>Receive vitamin D supplements. | Dietary Supplement: vitamin D<br>* Subject will receive vitamin d supplements<br>|
| Placebo Comparator: Placebo<br>Receive placebo pills | Other: Placebo<br>* Subject will receive a placebo.<br>|
| No Intervention: Tanning bed user<br>Regular tanning bed users will be assessed for their vitamin D levels. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary outcome measures include evaluation of changes in other laboratory parameters associated with change in vitamin D level. |  | 3 months |