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

Northwestern University

Status: Completed

Conditions: Vitamin D Deficiency

Treatments: Other: Placebo; Dietary Supplement: vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT00882505

STU8461

Details and patient eligibility

About

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.

Enrollment: 67 patients

Sex: Female

Ages: 18 to 47 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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67 participants in 3 patient groups, including a placebo group

Vitamin D supplement

Experimental group

Description:

Receive vitamin D supplements.

Treatment:

Dietary Supplement: vitamin D

Placebo

Placebo Comparator group

Description:

Receive placebo pills

Treatment:

Other: Placebo

Tanning bed user

No Intervention group

Description:

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