Efficacy of Cholecalciferol in Managing Vitamin D Deficiency and Insufficiency in Postmenopausal Women: A Clinical Evaluation

The primary objective of this study is to evaluate the **efficacy** of Cholecalciferol in postmenopausal women with vitamin D deficiency or insufficiency. This is clinically relevant as vitamin D plays a crucial role in bone health, and its deficiency is common in postmenopausal women, potentially leading to osteoporosis and increased fracture risk.

Secondary objectives include:

• Assessing the efficacy of maintenance doses of Cholecalciferol.
• Evaluating patient satisfaction with the supplement.

The clinical trial focuses on evaluating the **efficacy** of Cholecalciferol in **postmenopausal women** with vitamin D deficiency or insufficiency. The study population comprises exclusively female participants aged 45 years and older, who have experienced more than one year of amenorrhea. Participants are required to have a vitamin D level of less than 20 ng/ml to be classified as deficient, or between 20-30 ng/ml to be considered insufficient. The trial does not include male subjects or vulnerable populations. The sponsor has not provided information regarding the total number of participants. Participants were selected based on their willingness to participate and their ability to comprehend the study's nature, as evidenced by their signed informed consent. No specific lifestyle considerations such as diet or physical activity are mentioned in the available data.

The clinical trial is designed to evaluate the **efficacy** of **cholecalciferol** in postmenopausal women with **vitamin D deficiency** or insufficiency. This is a Phase III, randomized, double-blind, controlled trial, categorized as low intervention due to the use of authorized medicinal products in accordance with their marketing authorization. The trial is expected to last for approximately one year, with recruitment starting on June 1, 2023, and estimated completion by June 1, 2024.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to confirm eligibility based on criteria such as age (≥ 45 years), menopausal status, and vitamin D levels. Following the screening, participants will be randomized into one of four groups to receive varying doses of cholecalciferol. The primary endpoint involves serum vitamin D titration at the initial visit, third visit, and final visit to assess the treatment's efficacy. Secondary endpoints include evaluating vitamin D levels across groups and assessing patient satisfaction with the treatment.

The trial will include several follow-up visits to monitor participants' progress and ensure adherence to the protocol. The end-of-study visit will conclude the trial, where final assessments will be conducted. Participant involvement is expected to last up to four months, corresponding to the maximum treatment period. Conditions that may lead to early termination from the study include non-compliance with the study protocol, withdrawal of consent, or any adverse events that compromise participant safety.

The clinical trial involves the administration of **Lundeos 20,000 IU** soft capsules, which contain the active substance **colecalciferol**. This experimental medication is designed to address **vitamin D deficiency** and insufficiency in postmenopausal women. The pharmaceutical form of the medication is a soft capsule, facilitating oral administration. Each capsule contains 20,000 international units (IU) of colecalciferol. The maximum daily dose is set at 2,857 IU, with a total maximum dose of 80,000 IU over the course of the treatment. The treatment period is limited to a maximum of four weeks. The medication is manufactured by Theramex Ireland Limited and is not classified as a pediatric formulation or an orphan drug.

In this study, no non-experimental treatments such as standard-of-care therapy, placebo, or comparator treatments are utilized. The focus is solely on the efficacy of colecalciferol in the specified patient population. Participants' compliance with the dosing schedule is monitored throughout the trial to ensure adherence to the prescribed regimen. The trial aims to evaluate the required dose of colecalciferol for effective management of vitamin D deficiency and insufficiency in the target demographic.

Efficacy in this clinical trial will be assessed by evaluating the use of **cholecalciferol** in postmenopausal women with vitamin D deficiency or insufficiency. The primary endpoint involves serum vitamin D titration, which will be measured at the initial visit, the third visit, and the final visit. This will allow for the assessment of changes in vitamin D levels over the course of the treatment period. Secondary endpoints include evaluating vitamin D levels across four groups to determine if normal levels are maintained with a dosage of 1000 IU. Additionally, patient satisfaction with the treatment will be assessed. These efficacy parameters will be collected and analyzed at specified timepoints to ensure a comprehensive evaluation of the treatment's impact on vitamin D levels and patient satisfaction.