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Study on Improving Bone Health in Children with Cystic Fibrosis Using Cholecalciferol

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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 children with cystic fibrosis, a genetic condition that affects the lungs and other organs, including the bones. The study aims to explore ways to improve bone health in these children, who often face challenges with bone metabolism, bone density, and muscle strength. The treatment being tested is a form of vitamin D called cholecalciferol, which is given as oral drops. The study will compare two different daily doses of cholecalciferol: 6000 IU and 1000 IU, to see which is more effective in improving bone health over a period of two years.

The purpose of the study is to determine if the higher dose of 6000 IU of cholecalciferol is better at normalizing bone metabolism and enhancing bone density and muscle strength in children with cystic fibrosis. Participants will receive either the higher dose or the lower dose of cholecalciferol, and some may receive a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving which treatment, to ensure unbiased results.

Throughout the study, participants will have regular check-ups to monitor their health and measure the effects of the treatment. These check-ups will include assessments of vitamin D levels, bone density, and muscle strength. The study is expected to last for two years, providing valuable insights into the potential benefits of higher doses of cholecalciferol for improving bone health in children with cystic fibrosis.

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
Initial visit and consent
The study begins with an initial visit where the diagnosis of cystic fibrosis is confirmed. The age of the participant should be between 6 and 16 years.
The parent or legal representative must provide informed consent for the child's participation in the study.
Step 2
Randomization and medication assignment
Participants are randomly assigned to receive either 6000 IU or 1000 IU of cholecalciferol daily.
The medication is administered as oral drops using the product named Vigantol 0.5 mg/ml.
Step 3
Medication administration
The assigned dosage of cholecalciferol is taken daily for a duration of two years.
The medication is taken orally as a solution.
Step 4
Scheduled visits and assessments
Regular visits are scheduled to monitor the participant's health and progress.
During visits V3 to V7, blood tests are conducted to measure serum concentrations of 25-OH vitamin D and parathormone.
At visit V7, assessments of lumbar spine bone density and dynamic muscle force and power are performed.
Step 5
Completion of study
The study is estimated to conclude by January 1, 2027.
Final assessments are conducted to evaluate the effectiveness of the treatment in normalizing bone metabolism and improving bone density and muscle force.

Who can join the trial?

4 criteria

The child must have a diagnosis of cystic fibrosis. This is a genetic condition that affects the lungs and other organs.
The child must be between the ages of 6 and 16 years old, including those ages.
The parent or legal representative must be willing to sign a document called an informed consent, which means they agree to let the child participate in the study after understanding what it involves.
If the participant is a girl who can have children, she must agree to use appropriate methods to prevent pregnancy during the study, following specific guidelines.

Who cannot join the trial?

10 criteria

Children who do not have cystic fibrosis. Cystic fibrosis is a genetic condition that affects the lungs and digestive system.
Children who do not have problems with bone metabolism. Bone metabolism refers to the process by which bones are formed and broken down in the body.
Children who do not have issues with bone density. Bone density is a measure of how strong and dense the bones are.
Children who do not have problems with skeletal muscle force. Skeletal muscle force refers to the strength of the muscles that are attached to bones.
Children who are not within the specified age range for the study.
Children who are not able to take the study medication as required.
Children who have any other medical conditions that might interfere with the study.
Children who are taking medications that could affect the study results.
Children who have participated in another clinical trial recently.
Children whose parents or guardians do not give consent for them to participate.

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Fakultni nemocnice Motol a Homolka
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Prague, Czechia

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Investigated drugs

Cholecalciferol is a form of vitamin D used in this study to help improve bone health in children with cystic fibrosis. The trial aims to see if a higher amount of cholecalciferol is better than a lower amount in improving bone metabolism, bone density, and muscle strength.

Colecalciferol

What is already known about the treatment

Cholecalciferol – Cholecalciferol, commonly known as Vitamin D3, is administered orally in the form of tablets or liquid. It is currently being studied in clinical trials to assess its effectiveness in improving bone health in children with cystic fibrosis. The main therapeutic indication is to enhance bone metabolism, increase bone density, and improve skeletal muscle strength. At the molecular level, cholecalciferol works by promoting calcium absorption in the gut and maintaining adequate serum calcium and phosphate concentrations, which are necessary for normal bone mineralization. It is classified as a vitamin supplement and plays a crucial role in bone health and muscle function.

Investigated diseases

Cystic Fibrosis
Cystic fibrosis is a genetic disorder that affects the respiratory and digestive systems. It is characterized by the production of thick, sticky mucus that can clog the airways and lead to respiratory infections. Over time, this can cause damage to the lungs and other organs. The disease also affects the pancreas, leading to difficulties in digesting food and absorbing nutrients. People with cystic fibrosis may experience persistent coughing, frequent lung infections, and difficulty breathing. The condition is progressive, meaning it tends to worsen over time.
Bone Metabolism Disorders
Bone metabolism disorders involve abnormalities in the processes that regulate bone formation and resorption. These disorders can lead to changes in bone density and strength, potentially resulting in conditions like osteoporosis. Individuals with bone metabolism disorders may experience bone pain, fractures, or deformities. The balance between bone formation and breakdown is disrupted, affecting overall skeletal health. These disorders can be influenced by hormonal changes, nutritional deficiencies, or genetic factors. They often require careful monitoring to prevent complications related to bone health.