Evaluation of Colecalciferol Supplementation on Free Testosterone Levels in Men with Type 2 Diabetes Mellitus: A Placebo-Controlled Randomized Trial

The primary objective of this study is to evaluate the effect of **vitamin D** supplementation on increasing low free testosterone levels in men with **Type 2 Diabetes Mellitus** (T2D). This is clinically relevant as low testosterone levels in men with T2D can contribute to various health issues, including reduced muscle mass, increased body fat, and decreased quality of life. By potentially increasing free testosterone levels, vitamin D supplementation may offer a therapeutic benefit in managing these complications associated with T2D.

The clinical trial focuses on **Type 2 Diabetes Mellitus** and involves a study population of Caucasian men aged between 18 and 65 years. The participants are selected based on specific health criteria, including a body mass index (BMI) of less than 40 kg/m² and an HbA1c level of 64 mmol/mol (8%) or lower. The trial targets individuals with low vitamin D levels, specifically below 75 nmol/L, and a total testosterone level of less than 11 nmol/L. The study does not include female subjects or vulnerable populations. The sponsor has not provided information regarding the total number of participants. The trial aims to evaluate the effect of vitamin D supplementation on increasing low free testosterone levels in men with type 2 diabetes.

The clinical trial is designed to evaluate the effect of **vitamin D** supplementation on free testosterone levels in men with **Type 2 Diabetes Mellitus** and low testosterone levels. This study is a **randomized, placebo-controlled, double-blind** trial, ensuring that neither the participants nor the researchers know who is receiving the active treatment or the placebo, thus minimizing bias. The trial is categorized as a Phase 4 study, focusing on the therapeutic use of the intervention. The trial is expected to run from the estimated recruitment start date of November 22, 2019, to the estimated end date of December 31, 2030.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on criteria such as **vitamin D** levels below 75 nmol/L, age between 18 and 65 years, and a body mass index (BMI) of less than 40 kg/m². Eligible participants will be Caucasian men with **Type 2 Diabetes Mellitus**, an HbA1c level of 64 mmol/mol (8%) or less, and total testosterone levels below 11 nmol/L. Following the screening, participants will be randomly assigned to receive either the active treatment, **D-Cure 25,000 U.I. oral solution**, or a placebo. The primary endpoint is the change in free testosterone concentration after 10 days and 3 months of treatment.

Study visits will include follow-up assessments at specified intervals to monitor the participants' health and the effects of the treatment. The end-of-study visit will conclude the trial for each participant, where final assessments will be conducted. The expected length of participant involvement is up to 3 months, corresponding to the maximum treatment period. Conditions that may lead to early termination from the study include adverse reactions to the treatment, withdrawal of consent, or any significant protocol deviations. The trial aims to provide valuable insights into the potential benefits of **vitamin D** supplementation in this specific patient population.

The clinical trial involves the administration of **D-Cure 25.000 U.I., solution buvable**, an **oral solution** containing the active substance **colecalciferol**. This pharmaceutical form is designed for oral administration and is provided by LABORATOIRES SMB S.A. The solution is intended to be used in a dosage form of 25,000 international units (IU) per milliliter. The maximum daily dose permitted in the trial is 400,000 IU, with a total maximum dose of 4,800,000 IU over the course of the study. The treatment period is limited to a maximum of three months. The administration route is strictly oral, and the formulation is not specifically designed for pediatric use. The active substance, colecalciferol, is of chemical origin and is classified under the ATC code A11CC05.

In this study, the primary objective is to evaluate the effect of vitamin D supplementation on increasing free testosterone levels in men with Type 2 Diabetes Mellitus who have low testosterone levels. The trial is placebo-controlled and randomized to ensure the reliability of the results. Participants' compliance with the dosing schedule will be monitored throughout the study to ensure adherence to the treatment protocol. No additional non-experimental treatments, such as standard-of-care therapy or comparator treatments, are specified in the trial documentation. The study is designed to assess the therapeutic potential of colecalciferol in the specified patient population, with careful monitoring of dosage and administration to ensure participant safety and data integrity.

Efficacy in this clinical trial will be assessed by evaluating the primary endpoint, which is the change in free testosterone concentration in men with Type 2 Diabetes Mellitus (T2D) and low testosterone levels. The assessment will occur at two specific timepoints: after 10 days and after 3 months of vitamin D supplementation. The trial aims to determine the effect of vitamin D on increasing free testosterone levels in the target population. The primary endpoint will be measured using appropriate laboratory tests to quantify free testosterone levels, ensuring accurate and reliable data collection. The trial is designed as a placebo-controlled, randomized clinical trial, which will help in objectively assessing the efficacy of vitamin D supplementation in the specified cohort.