University of Southern California Health Sciences Campus Center for Health Professions
Los Angeles, California, 90033, United States
NCT Number: NCT06610968
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.
This study is active but is not currently recruiting participants.
Notify Me18 year–35 year
Female
Interventional
Not applicable
Los Angeles, California, 90033, United States
High-dose Vitamin D supplementation significantly increases testosterone in men, but research about Vitamin D's effect on testosterone in young, healthy females is limited [1]. However, testosterone is a critical hormone for many physiologic functions in females including maintenance of reproductive health, cognitive function, body composition, mental health, bone density, muscle strength, and much more. Thus, this study aims to investigate the effect of Vitamin D supplementation on testosterone and gonadotropin concentrations in premenopausal, healthy females. The study investigators hypothesize that Vitamin D supplementation will result in a significant increase in circulating Vitamin D [25(OH)D], testosterone, and sex hormone modulators (i.e., gonadotropins and SHBG) concentrations in pre-menopausal females and that the magnitude of testosterone increase will be inversely related to fat mass and BMI. 20 young, healthy females will be randomized to either a treatment or placebo group for a three-week intervention, where the control group will take 5000 IU of Vitamin D orally, daily and the placebo group will take a placebo capsule orally, daily. Circulating Vitamin D, testosterone, gonadotropin, and SHBG concentrations will be assessed via serum pre- and post-intervention. Two-tailed unpaired t-test will be conducted to assess the relative change in total testosterone and free testosterone levels between the groups. Additionally, correlation analyses will be performed for correlations between body composition metrics and 25(OH)D, testosterone, and sex hormone modulator concentrations.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
5000 IU Vitamin D (as cholecalciferol) capsules (Vitamin D3 125 mcg [5,000 IU], Pure Encapsulation, LLC) daily
Other names: 5000 IU Vitamin D daily
One placebo capsule (Zeebo Imagine, Zeebo) daily.
Other names: Placebo (Zeebo) pill daily
Time frame: 3 weeks
The primary objective is to evaluate the effect of acute Vitamin D supplementation on systemic Vitamin D, testosterone, and sex hormone modulators in pre-menopausal, healthy females. Circulating testosterone (total testosterone and free testosterone) concentrations (ng/dL) will be assessed via serum pre- and post-Vitamin D intervention.
Time frame: 3 weeks
The primary objective is to evaluate the effect of acute Vitamin D supplementation on systemic Vitamin D, testosterone, and sex hormone modulators in pre-menopausal, healthy females. Circulating Vitamin D [25(OH)D] concentrations (ng/dL) will be assessed via serum pre- and post-Vitamin D intervention.
Time frame: 3 weeks
The primary objective is to evaluate the effect of acute Vitamin D supplementation on systemic Vitamin D, testosterone, and sex hormone modulators in pre-menopausal, healthy females. Circulating gonadotropins (LH and FSH) concentrations (IU/L) will be assessed via serum pre- and post-Vitamin D intervention.
Time frame: 3 weeks
The primary objective is to evaluate the effect of acute Vitamin D supplementation on systemic Vitamin D, testosterone, and sex hormone modulators in pre-menopausal, healthy females. Circulating SHBG concentrations (nmol/L) will be assessed via serum pre- and post-Vitamin D intervention.
Time frame: 3 weeks
Secondary analyses will evaluate the effect of body composition on change in testosterone concentration due to acute Vitamin D supplementation of pre-menopausal, healthy females. Testosterone (TT and FT) concentrations will be correlated with body composition metrics, i.e. fat and fat-free mass (kg), pre- and post-Vitamin D intervention.
Time frame: 3 weeks
Secondary analyses will evaluate the effect of body composition on change in testosterone concentration due to acute Vitamin D supplementation of pre-menopausal, healthy females. Testosterone (TT and FT) concentrations will be correlated with body composition metrics, i.e. BMI (kg/m^2) as measured from height (m) and weight (kg), pre- and post-Vitamin D intervention.
University of Southern California
Other
Effects of Acute Vitamin D Supplementation on Testosterone in Young, Healthy Females: A Pilot Study
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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.