Study on the Required Dose of Cholecalciferol for Managing Vitamin D Deficiency in Postmenopausal Women

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for vitamin D deficiency and insufficiency in postmenopausal women. The treatment being tested is a medication called Cholecalciferol, which is a form of vitamin D. The purpose of the study is to determine the required dose of Cholecalciferol to effectively manage vitamin D levels in women who have gone through menopause and are experiencing low levels of this important vitamin.

Participants in the study will take Cholecalciferol in the form of soft capsules, known as Lundeos 20,000 UI. The study will involve several visits where vitamin D levels in the blood will be measured to see how well the treatment is working. The study will also look at how satisfied participants are with the treatment. The treatment is taken orally, which means it is swallowed like a regular pill.

The study will help to understand how much Cholecalciferol is needed to maintain healthy vitamin D levels in postmenopausal women. This is important because vitamin D plays a crucial role in bone health and overall well-being. By participating in this study, researchers hope to find the best way to support women who are experiencing vitamin D deficiency or insufficiency after menopause.

1 initial visit

Upon joining the study, an initial visit is scheduled. During this visit, a blood test is conducted to measure your current vitamin D levels. This helps determine the starting point for your treatment.

You will receive a detailed explanation of the study, including the purpose and procedures involved. Any questions you have will be addressed to ensure you understand the process.

You will be asked to sign a consent form, confirming your willingness to participate in the study.

2 medication administration

You will be provided with Lundeos 20,000 UI soft capsules, which contain the active ingredient cholecalciferol (a form of vitamin D).

The medication is taken orally. The dosage and frequency will be explained to you during the initial visit, ensuring you understand how to take the medication correctly.

3 follow-up visits

Throughout the study, you will have scheduled follow-up visits. These visits are important for monitoring your progress and adjusting the treatment if necessary.

During these visits, additional blood tests will be conducted to measure your vitamin D levels. This helps evaluate the effectiveness of the treatment.

4 final visit

At the end of the study, a final visit is conducted. This visit includes a final blood test to assess your vitamin D levels after completing the treatment.

Your satisfaction with the treatment will be evaluated, and any remaining questions or concerns will be addressed.

Who Can Join the Study?

Must be a female patient.
Must be aged 45 years or older.
Must be a postmenopausal woman, meaning she has not had a menstrual period for more than one year.
Must have a vitamin D deficiency (less than 20 ng/ml) or vitamin D insufficiency (between 20-30 ng/ml). Vitamin D levels are measured in the blood.
Must be willing to participate and able to understand the explanation about the study.
Must provide written informed consent, which means agreeing in writing to take part in the study after being informed about it.

Who Cannot Join the Study?

Men cannot participate in the study. Only women are eligible.
Women who are not postmenopausal cannot participate. Postmenopausal means the time after a woman has stopped having menstrual periods.
Women who do not have a deficiency or insufficiency of vitamin D cannot participate. A deficiency or insufficiency means having lower than normal levels of vitamin D in the body.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Clinica Palacios Madrid S.L.	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	01.06.2023

Trial locations

Investigated drugs:

Colecalciferol

Cholecalciferol is a form of vitamin D that is used to help manage vitamin D deficiency or insufficiency. In this clinical trial, it is being tested to see how effective it is for postmenopausal women who have low levels of vitamin D. Vitamin D is important for maintaining healthy bones and supporting the immune system. This trial aims to find out how well Cholecalciferol works in improving vitamin D levels in these women.

Investigated diseases:

Vitamin D Deficiency – Vitamin D deficiency occurs when the level of vitamin D in the body is too low. This condition can lead to bone problems, as vitamin D is crucial for maintaining bone health by helping the body absorb calcium. Initially, individuals may not notice any symptoms, but over time, it can cause bone pain and muscle weakness. In severe cases, it can lead to more serious bone disorders such as osteomalacia in adults. The progression of the deficiency can be slow, and symptoms may develop gradually. Regular monitoring of vitamin D levels can help in understanding the progression of this condition.

Trial ID:

2023-504664-42-02

Protocol code:

IP-VITD

Trial Phase:

Therapeutic confirmatory (Phase III)

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