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

NCT00882505 | Completed

• 1 other identifier: STU8461
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

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

  3 months

Study Arms (3)

Vitamin D supplement

EXPERIMENTAL

Receive vitamin D supplements.

Dietary Supplement: vitamin D

Placebo

PLACEBO COMPARATOR

Receive placebo pills

Other: Placebo

Tanning bed user

NO INTERVENTION

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

Interventions

vitamin D DIETARY_SUPPLEMENT

Subject will receive vitamin d supplements

Vitamin D supplement

Placebo OTHER

Subject will receive a placebo.

Placebo

Eligibility Criteria

• Age: 18 Years - 47 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Murad Alam, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Dermatology, Otolaryngology- Head and Neck Surgery, and Surgery-Organ Transplantation

Study Record Dates

• First Submitted: April 15, 2009
• First Posted: April 16, 2009
• Study Start: April 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: December 2, 2021

Record last verified: 2021-11

Locations

US (1)