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Vitamin Supplement

Vitamin D Supplementation for Hormonal Imbalance

N/A
Waitlist Available
Led By Giuliet L Kibler
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Weight greater than or equal to 110 lbs
Assigned female at birth
Must not have
Weight less than 110 lbs
Taking exogenous hormones
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 weeks

Summary

This trial involves two visits to the Clinical Exercise Research Center at the University of Southern California Health Sciences Campus. During the first visit, participants will have their height, weight, and body composition measured. They

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects from high-dose Vitamin D may include nausea, vomiting, constipation, weakness or fatigue. However, many people do not experience any side effects at all.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I weigh at least 110 lbs.
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I was assigned female at birth.
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I am between 18 and 35 years old.
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I don't have chronic diseases that affect Vitamin D uptake or sensitivity.
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I do not have any diagnosed gynecological conditions.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I weigh less than 110 lbs.
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I am taking hormone medications.
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I have a chronic condition that affects how my body uses Vitamin D.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Hormonal Effects of Vitamin D in Young, Healthy Women
Secondary study objectives
Effects of Body Composition on Hormonal Changes Due to Vitamin D Supplementation in Young, Healthy Women

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Vitamin D GroupExperimental Treatment1 Intervention
The treatment intervention will consist of three weeks of one 5000 IU cholecalciferol capsule (Pure Encapsulations, LLC) daily, with breakfast.
Group II: Placebo GroupPlacebo Group1 Intervention
The control group will also take a daily, with breakfast, placebo capsule (Zeebo) for the three-week intervention.

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor
944 Previous Clinical Trials
1,604,625 Total Patients Enrolled
Giuliet L KiblerPrincipal InvestigatorUniversity of Southern California - Division of Biokinesiology and Physical Therapy
~13 spots leftby Jan 2025
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