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Ergocalciferol Bp

This article examines the use of Ergocalciferol BP, a form of vitamin D2, in clinical trials for patients with Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM). While the primary focus of the trial is on the drug eplontersen, Ergocalciferol BP is included as part of a multivitamin supplement called Concavit Capsules. We’ll explore the potential benefits and implications of using this vitamin in conjunction with the main treatment for ATTR-CM patients.

Table of Contents

What is ERGOCALCIFEROL BP?

ERGOCALCIFEROL BP, also known as Vitamin D2, is an essential nutrient that plays a crucial role in maintaining overall health[1]. It is one of the active ingredients in a medication called Concavit Capsules, which is a multivitamin preparation. ERGOCALCIFEROL BP is specifically designed to meet the British Pharmacopoeia (BP) standards, ensuring its quality and consistency.

Uses of ERGOCALCIFEROL BP

ERGOCALCIFEROL BP is primarily used to prevent and treat vitamin D deficiency. Vitamin D is essential for several bodily functions, including:

  • Promoting calcium absorption in the gut
  • Maintaining strong bones and teeth
  • Supporting muscle function
  • Aiding in immune system regulation

While the clinical trial data provided doesn’t specifically mention the uses of ERGOCALCIFEROL BP, it’s important to note that vitamin D deficiency can lead to various health issues, including weakened bones, muscle weakness, and an increased risk of fractures[1].

Formulation and Other Ingredients

ERGOCALCIFEROL BP is part of a multivitamin formulation called Concavit Capsules. These capsules contain several other vitamins and nutrients, including[1]:

  • Nicotinamide BP (Vitamin B3)
  • Riboflavin BP (Vitamin B2)
  • All-rac-alpha-tocopheryl acetate BP (Vitamin E)
  • Calcium pantothenate BP (Vitamin B5)
  • Thiamine nitrate BP (Vitamin B1)
  • Vitamin A BP
  • Ascorbic acid BP (Vitamin C)
  • Pyridoxine hydrochloride BP (Vitamin B6)

This combination of vitamins is designed to provide a comprehensive nutritional supplement to support overall health and well-being.

How is ERGOCALCIFEROL BP Administered?

Concavit Capsules, which contain ERGOCALCIFEROL BP, are administered orally. The capsules are soft, making them easier to swallow[1]. It’s important to take the capsules as directed by your healthcare provider or as indicated on the product label.

Dosage Information

The clinical trial data provides some information about the dosage of ERGOCALCIFEROL BP in Concavit Capsules:

  • The maximum daily dose is 3000 IU (International Units)[1].
  • The maximum total dose amount is 3,285,000 IU[1].
  • The maximum treatment period mentioned is 36 months (3 years)[1].

It’s crucial to follow the dosage instructions provided by your healthcare provider, as they will consider your individual needs and health status.

Potential Benefits

While the clinical trial data doesn’t specifically outline the benefits of ERGOCALCIFEROL BP, we can infer some potential advantages based on its role as a vitamin D supplement:

  • Improved bone health and reduced risk of fractures
  • Enhanced muscle strength and function
  • Support for the immune system
  • Potential mood improvement, especially in cases of vitamin D deficiency

The multivitamin nature of Concavit Capsules suggests that it may provide a range of nutritional benefits beyond just vitamin D supplementation[1].

Important Considerations

When taking ERGOCALCIFEROL BP or any vitamin supplement, keep the following in mind:

  • Always consult with your healthcare provider before starting any new supplement regimen.
  • Inform your doctor about any other medications or supplements you’re taking to avoid potential interactions.
  • Follow the recommended dosage carefully. Excessive vitamin D intake can lead to toxicity.
  • If you experience any unusual symptoms or side effects, contact your healthcare provider immediately.
  • Store the medication as directed on the label, typically in a cool, dry place away from direct sunlight.

Remember, while ERGOCALCIFEROL BP and other vitamins in Concavit Capsules are essential for health, they are not a substitute for a balanced diet and healthy lifestyle. Always aim to obtain nutrients from a variety of food sources in addition to any prescribed supplements[1].

Aspect Details
Study Type Open-label extension study
Main Drug Eplontersen (ION-682884)
Condition Studied Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)
Primary Objectives Evaluate safety and tolerability of extended eplontersen dosing
Secondary Objectives Assess efficacy parameters in overall population and subgroups
Key Measurements Safety lab assessments, biomarkers, clinical tests, imaging tests, quality of life questionnaires
Ergocalciferol BP Role Part of Concavit Capsules multivitamin supplement
Study Duration Up to 36 months

FAQ

  • What is Ergocalciferol BP and why is it used in this clinical trial? Ergocalciferol BP is a form of vitamin D2. In this trial, it's part of a multivitamin supplement called Concavit Capsules. While not the main focus of the study, it's included to ensure patients maintain adequate vitamin levels during the trial.
  • What is the main purpose of the clinical trial? The main purpose of the trial is to evaluate the long-term safety and tolerability of eplontersen in patients with Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM). The trial also aims to assess the drug's efficacy in these patients.
  • Who can participate in this clinical trial? Participants must have completed the treatment period and end-of-treatment visit of a previous study (ION-682884-CS2) or have a diagnosis of ATTR-CM and satisfactory participation in another study (ISIS 420915CS101). They must also be willing to take vitamin A supplements as per the protocol.
  • What are some of the key measurements taken during the trial? The trial measures various safety indicators, including platelet count, kidney function, liver function, and thyroid panel tests. It also assesses the effectiveness of the treatment through biomarkers, clinical tests like the 6-minute walk test, and quality of life questionnaires.
  • How long does the trial last? The trial can last up to 36 months (3 years) for each participant. This extended period allows researchers to evaluate the long-term effects and safety of the treatment.

Ongoing Clinical Trials on Ergocalciferol Bp

  • Study on Long-Term Safety of Eplontersen for Adults with Transthyretin-Mediated Amyloid Cardiomyopathy

    Recruiting

    1 1 1 1
    Investigated drugs:
    Austria Belgium Czechia Denmark France Germany +6

Glossary

  • Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM): A type of heart disease where abnormal proteins called amyloids build up in the heart, affecting its function.
  • Eplontersen: The main drug being studied in this trial for the treatment of ATTR-CM.
  • Ergocalciferol BP: A form of vitamin D2 included in the multivitamin supplement given to patients in the trial.
  • Open-label extension study: A type of clinical trial where both researchers and participants know which treatment is being given, often following a previous study to gather long-term data.
  • Biomarkers: Measurable indicators in the body that can show the presence or progress of a disease or the effects of a treatment.
  • 6-minute walk test (6MWT): A test that measures the distance a person can walk in 6 minutes, used to assess physical function and endurance.
  • Quality of life questionnaires: Surveys that assess how a patient's health condition affects their daily life and overall well-being.
  • Echocardiogram (ECHO): An ultrasound test that produces images of the heart to assess its structure and function.
  • Anti-drug Antibody (ADA): Antibodies produced by the body in response to a medication, which can affect the drug's effectiveness or cause side effects.
  • Transthoracic echocardiogram: An ultrasound of the heart performed by placing the ultrasound probe on the chest wall.

References

  1. http://clinicaltrials.eu/trial/study-on-long-term-safety-of-eplontersen-for-adults-with-transthyretin-mediated-amyloid-cardiomyopathy/