Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06610968
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-17
Brief Title:
Acute Vitamin D Supplementation on Testosterone in Females
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Acute Vitamin D Supplementation on Testosterone in Young Healthy Females a Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 ie rolling a die and participants are blinded to group assignment
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 ie rolling a die and participants are blinded to group assignment
Detailed Description:
High-dose Vitamin D supplementation significantly increases testosterone in men but research about Vitamin Ds 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 25OHD testosterone and sex hormone modulators ie 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 25OHD testosterone and sex hormone modulator concentrations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None