Effects of Acute Vitamin D Supplementation on Testosterone in Young, Healthy Females: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Hormonal Effects of Vitamin D in Young, Healthy Women
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
盲法说明
Single blinded intervention. Those measuring the blood samples' hormonal will also be blinded to the intervention group but will not have a role in data analysis.
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Assigned female at birth
- •18 to 35 years of age
- •No chronic diseases affecting the uptake of Vitamin D or causing Vitamin D sensitivity (e.g., sarcoidosis, tuberculosis, Wegener's granulomatosis, other forms of vasculitis, inflammatory bowel diseases, etc.) [21]
- •Completion and signature of the informed consent document
- •Non-pregnant or trying to become pregnant
- •No supplementation with Vitamin D within three months of enrollment
- •No documented gynecological disease (e.g., PCOS, endometriosis, etc.)
- •Weight greater than or equal to 110 lbs
排除标准
- •Supplementation with Vitamin D within three months of enrollment
- •Taking exogenous hormones
- •Documented gynecological disease (e.g., PCOS, endometriosis, etc.)
- •Suffering from chronic diseases affecting the uptake of Vitamin D or causing Vitamin D sensitivity (e.g., sarcoidosis, tuberculosis, Wegener's granulomatosis, other forms of vasculitis, inflammatory bowel diseases, etc.) [21]
- •Weight less than 110 lbs
结局指标
主要结局
Hormonal Effects of Vitamin D in Young, Healthy Women
时间窗: 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.
次要结局
- Effects of Body Composition on Hormonal Changes Due to Vitamin D Supplementation in Young, Healthy Women(3 weeks)
研究者
Todd Schroeder
Professor
University of Southern California