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Study on Vitamin D (Colecalciferol) to Increase Free Testosterone in Men with Type 2 Diabetes and Low Testosterone Levels

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on men with Type 2 Diabetes Mellitus, a condition where the body struggles to regulate blood sugar levels effectively. The study is investigating the effects of a treatment using Vitamin D, specifically a product called D-Cure 25,000 U.I., solution buvable, which is an oral solution containing the active substance colecalciferol. The purpose of the study is to see if taking Vitamin D can help increase low levels of free testosterone, a hormone important for male health, in men who have Type 2 Diabetes and low testosterone levels.

Participants in the study will receive either the Vitamin D treatment or a placebo. The study will observe changes in free testosterone levels over a period of 10 days and then again after 3 months. This will help researchers understand if Vitamin D supplementation can effectively increase testosterone levels in the participants.

The trial aims to provide valuable insights into whether Vitamin D can be a beneficial treatment for men with Type 2 Diabetes who also have low testosterone levels. By participating in this study, researchers hope to gather important data that could lead to improved treatment options for this group of patients.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment
Upon joining the study, eligibility is confirmed based on specific criteria such as age, vitamin D levels, and testosterone levels.
Participants must be Caucasian men aged 18 to 65 years with type 2 diabetes and a body mass index (BMI) less than 40 kg/m².
Step 2
Initial assessment
An initial assessment is conducted to measure baseline levels of vitamin D and free testosterone.
This assessment helps in evaluating the effect of the treatment over time.
Step 3
Treatment phase
Participants receive an oral solution called D-Cure 25.000 U.I., which contains colecalciferol, a form of vitamin D.
The treatment aims to increase free testosterone levels in men with type 2 diabetes.
The oral solution is administered as per the study protocol, with specific dosages and frequency determined by the research team.
Step 4
Follow-up assessments
Follow-up assessments are conducted after 10 days and 3 months to measure changes in free testosterone concentration.
These assessments help in determining the effectiveness of the vitamin D supplementation.
Step 5
Completion
The study is estimated to conclude by December 31, 2030.
Final results will be analyzed to understand the impact of vitamin D on testosterone levels in the study population.

Who can join the trial?

7 criteria

Must have a **vitamin D** level less than 75 nmol/L. Vitamin D is a nutrient important for bone health and other body functions.
Must be a **Caucasian man**. This refers to men of European descent.
Must be between the ages of 18 and 65 years old.
Must have a **BMI** less than 40 kg/m². BMI, or Body Mass Index, is a measure of body fat based on height and weight.
Must have **Type 2 Diabetes Mellitus**. This is a condition where the body does not use insulin properly, leading to high blood sugar levels.
Must have an **HbA1c** level of 64 mmol/mol or less, which is equal to 8% or less. HbA1c is a blood test that shows average blood sugar levels over the past 2 to 3 months.
Must have a **total testosterone** level less than 11 nmol/L. Testosterone is a hormone important for male development and health.

Who cannot join the trial?

5 criteria

Individuals who do not have Type 2 Diabetes Mellitus cannot participate. This is a condition where the body does not use insulin properly, leading to high blood sugar levels.
Women cannot participate in this study. Only men are eligible.
Individuals who do not have low levels of free testosterone cannot participate. Free testosterone is a hormone important for male health.
Individuals who are not within the specified age range cannot participate. The study is for certain age groups only.
Individuals who are part of a vulnerable population cannot participate. This means people who might need special protection or care.

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Verified sites

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Vrije Universiteit Brussel
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Jette, Belgium

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Investigated drugs

Vitamin D is being studied to see if it can help increase free testosterone levels in men who have type 2 diabetes and low testosterone levels. The trial aims to understand if taking vitamin D can improve testosterone levels in these patients.

Colecalciferol

What is already known about the treatment

Vitamin D – Vitamin D is typically administered orally in the form of tablets or capsules. It is currently being studied in clinical trials for its potential benefits in increasing free testosterone levels in men with Type 2 Diabetes Mellitus. The main therapeutic indication in this context is to address low testosterone levels in these patients. At the molecular level, Vitamin D is believed to influence testosterone production by interacting with vitamin D receptors in the body, which may play a role in hormone regulation. It is classified as a vitamin and is essential for maintaining bone health and supporting immune function.

Investigated diseases

Type 2 Diabetes Mellitus – This is a chronic condition that affects the way the body processes blood sugar (glucose). In type 2 diabetes, the body either resists the effects of insulin, a hormone that regulates the movement of sugar into cells, or doesn't produce enough insulin to maintain normal glucose levels. Over time, high blood sugar levels can lead to various complications, affecting the heart, blood vessels, nerves, eyes, and kidneys. The disease often develops slowly, and individuals may not notice symptoms initially. Common symptoms include increased thirst, frequent urination, hunger, fatigue, and blurred vision. Managing blood sugar levels is crucial to prevent complications associated with this condition.