Vitamin D Supplementation for Hormonal Imbalance

Recruiting in Palo Alto (17 mi)

Overseen by Giuliet L Kibler

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Southern California

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

Participation will take place over two visits to the Clinical Exercise Research Center (CERC) at the University of Southern California Health Sciences Campus. On the first visit, height, weight, and body composition by bioelectrical impedance are recorded. Questionnaires and withdrawal of a sample of blood (1 tablespoon) are also completed. The intervention begins the day following the first visit. The intervention protocol consists of three weeks of consuming either a placebo capsule or a 5000 IU Vitamin D capsule daily and completing a daily survey. The second visit to CERC immediately follows the 3-weeks intervention. In this visit, the same blood sampling protocol will be completed. The assignment of the intervention will be randomized (i.e., rolling a die), and participants are blinded to group assignment.

Research Team

Giuliet L Kibler

Principal Investigator

University of Southern California - Division of Biokinesiology and Physical Therapy

Eligibility Criteria

This trial is for females experiencing hormonal imbalance. Participants will need to visit the research center twice, complete questionnaires, and allow a small amount of blood to be drawn. They must take a daily capsule for three weeks and keep a survey diary.

Inclusion Criteria

I weigh at least 110 lbs.

I was assigned female at birth.

Completion and signature of the informed consent document

Exclusion Criteria

Pregnant

I have taken Vitamin D supplements in the last 3 months.

I weigh less than 110 lbs.

Treatment Details

Interventions

• Vitamin D (Vitamin Supplement)

Trial Overview The study tests if taking high-dose Vitamin D (5000 IU) affects testosterone levels compared to a placebo. It's randomized, meaning participants are put into the Vitamin D or placebo group by chance, and neither the researchers nor participants know who gets what until after the study.

Participant Groups

Group I: Vitamin D Group Experimental Treatment 1 Intervention

The treatment intervention will consist of three weeks of one 5000 IU cholecalciferol capsule (Pure Encapsulations, LLC) daily, with breakfast.

Group II: Placebo Group Placebo Group 1 Intervention

The control group will also take a daily, with breakfast, placebo capsule (Zeebo) for the three-week intervention.

Vitamin D is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Vitamin D for:

• Rickets
• Osteomalacia
• Osteoporosis
• Hypocalcemia
• Hyperparathyroidism
• Malabsorption states
• Cirrhosis
• Obesity

🇪🇺 Approved in European Union as Vitamin D for:

• Rickets
• Osteomalacia
• Osteoporosis
• Hypocalcemia
• Hyperparathyroidism
• Malabsorption states
• Cirrhosis
• Obesity

🇨🇦 Approved in Canada as Vitamin D for:

• Rickets
• Osteomalacia
• Osteoporosis
• Hypocalcemia
• Hyperparathyroidism
• Malabsorption states
• Cirrhosis
• Obesity

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Southern California Health Sciences Campus Center for Health Professions Los Angeles, CA

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Patients Recruited

1,609,000+

References