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Study on the Effects of Cholecalciferol and Glycerol on Inflammation in Obese Elderly Patients with Vitamin D Deficiency

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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 studying the effects of vitamin D on certain body tissues in elderly individuals who are obese and have a deficiency in vitamin D. The treatment being tested is a supplement called cholecalciferol, which is another name for vitamin D3. The study will also use olive oil as a comparison. The main goal is to understand how vitamin D supplementation affects inflammation, which is the body's response to injury or infection, in these individuals.

Participants in the study will take the vitamin D supplement or olive oil by mouth over a period of 12 months. Throughout the study, various tests will be conducted to monitor changes in the body. These tests will look at different tissues, including muscle, fat, and bone, to see how they respond to the treatment. The study will also measure levels of certain proteins and genes that are involved in inflammation and other bodily processes. Additionally, the safety of taking vitamin D will be checked by measuring blood calcium levels regularly.

The study aims to provide valuable information on how vitamin D can help manage inflammation in people who are both elderly and obese, with a specific focus on those who have low levels of vitamin D. This research could lead to better understanding and management of health issues related to vitamin D deficiency in this population. The study is expected to be completed by February 2027.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, body mass index (BMI), and vitamin D levels.
Participants must be post-menopausal women or men aged 55 to 75, with a BMI of 30 or higher, and vitamin D levels below 20 ng/ml.
Step 2
Consent and commitment
Participants provide written informed consent, agreeing to adhere to the study procedures.
Step 3
Medication administration
Participants receive cholecalciferol (vitamin D) and olive oil as part of the study medication.
Both substances are administered orally. The dosage and frequency are determined by the study protocol.
Step 4
Monitoring and evaluation
Regular monitoring of blood calcium levels is conducted to ensure safety during the supplementation period.
Participants undergo various tests to evaluate changes in inflammation markers, muscle, adipose, and bone tissue.
Step 5
Imaging and analysis
Magnetic resonance imaging (MRI) is used to assess muscle tissue, while other tests analyze gene and protein expression in adipose and bone tissues.
Blood samples are collected to measure cytokines and other markers related to inflammation and bone health.
Step 6
Study completion
The study is expected to conclude by February 28, 2027, with final assessments conducted to evaluate the overall effects of the supplementation.

Who can join the trial?

5 criteria

Provide written informed consent, which means you agree to participate in the study after understanding all the details.
Be willing to follow all the procedures and instructions given during the study.
Be a post-menopausal woman or a man between the ages of 55 and 75 who is scheduled for hip or knee replacement surgery.
Have a Body Mass Index (BMI) of 30 or higher. BMI is a measure that uses your height and weight to determine if you are overweight.
Have vitamin D levels below 20 ng/ml. Vitamin D levels are measured through a blood test to see if you have enough vitamin D in your body.

Who cannot join the trial?

5 criteria

Individuals who are not obese (having excess body weight) cannot participate.
Individuals who are not elderly (older adults) cannot participate.
Individuals who do not have a vitamin D deficiency (low levels of vitamin D in the body) cannot participate.
Individuals who are under the age of 18 cannot participate.
Individuals who are part of a vulnerable population (groups that may need special protection) cannot participate.

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Universita' Campus Bio-medico Di Roma
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Rome, Italy

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Investigated drugs

Cholecalciferol is a form of vitamin D used in this study to see how it affects inflammation in people who are obese and have a vitamin D deficiency. Vitamin D is important for maintaining healthy bones and muscles, and this study aims to understand its impact on inflammation, which is a common issue in obesity.

What is already known about the treatment

Cholecalciferol – Cholecalciferol is administered orally, typically in the form of tablets or capsules. It is currently well-established in medical literature as a form of vitamin D used to treat or prevent vitamin D deficiency. The main therapeutic indication for cholecalciferol is to support bone health and improve vitamin D levels, particularly in individuals with deficiencies. At the molecular level, cholecalciferol is converted in the body to its active form, calcitriol, which helps regulate calcium and phosphate metabolism, essential for maintaining healthy bones. It is classified pharmacologically as a vitamin supplement.

Investigated diseases

Obesity
Obesity is a condition characterized by excessive body fat accumulation, which can negatively impact health. It develops when calorie intake consistently exceeds calorie expenditure, leading to weight gain. Over time, obesity can contribute to various health issues, including joint problems, sleep apnea, and increased risk of certain diseases. The condition is often associated with a sedentary lifestyle and poor dietary habits. It can also be influenced by genetic, hormonal, and environmental factors. Managing obesity typically involves lifestyle changes, such as improved diet and increased physical activity.
Vitamin D Deficiency
Vitamin D deficiency occurs when there is an insufficient level of vitamin D in the body, which is essential for maintaining healthy bones and immune function. This deficiency can develop due to inadequate dietary intake, limited sun exposure, or certain medical conditions affecting absorption. Over time, it can lead to bone-related issues such as rickets in children and osteomalacia in adults. The deficiency may also contribute to muscle weakness and increased risk of infections. It is often identified through blood tests measuring vitamin D levels.