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 study about?

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Vrije Universiteit Brussel	Jette	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	22.11.2019

Trial locations

Investigated drugs:

Colecalciferol

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.

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.

Trial ID:

2024-514834-19-00

Trial Phase:

Therapeutic exploratory (Phase II)

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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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