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Completed

NCT Number: NCT00882505

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

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.

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 year–47 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D

Dietary Supplement

Subject will receive vitamin d supplements

Placebo

Other

Subject will receive a placebo.

Primary outcomes

  1. 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.

    Time frame: 3 months

  2. 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.

    Time frame: 3 months

Secondary outcomes

  1. The secondary outcome measures include evaluation of changes in other laboratory parameters associated with change in vitamin D level.

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 16, 2009
Registry last updated
Dec 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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