#1 Clinical Trials Search in Europe

Calcium Pantothenate Bp

This article discusses the use of Calcium Pantothenate BP, a component of Concavit Capsules, in clinical trials for Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM). While the primary focus of the trial is on eplontersen, Concavit Capsules, which contain Calcium Pantothenate BP along with other vitamins, are used as a supplementary treatment. We’ll explore the trial’s objectives, eligibility criteria, and potential benefits for patients with this rare heart condition.

Table of Contents

What is Calcium Pantothenate BP?

Calcium Pantothenate BP is a form of vitamin B5, also known as pantothenic acid. The “BP” in its name stands for “British Pharmacopoeia,” which indicates that it meets specific quality standards[1]. This vitamin is an essential nutrient that plays a crucial role in various bodily functions.

Uses and Benefits

Calcium Pantothenate BP is primarily used as a dietary supplement to prevent or treat vitamin B5 deficiency. It is included in multivitamin formulations like Concavit Capsules[1]. Some potential benefits of vitamin B5 include:

  • Supporting energy metabolism
  • Helping in the production of red blood cells
  • Maintaining a healthy digestive tract
  • Supporting the nervous system
  • Assisting in the synthesis of cholesterol, hormones, and neurotransmitters

Formulation and Administration

Calcium Pantothenate BP is available in Concavit Capsules, which are soft capsules intended for oral use[1]. These capsules are designed to be taken by mouth, usually with water. The soft capsule formulation may make them easier to swallow for some patients.

Other Ingredients in Concavit Capsules

Concavit Capsules contain several other vitamins and nutrients along with Calcium Pantothenate BP[1]. These include:

  • Ergocalciferol BP: Also known as vitamin D2, it helps in calcium absorption and bone health.
  • Nicotinamide BP: A form of vitamin B3, important for energy metabolism.
  • Riboflavin BP: Also called vitamin B2, it’s crucial for energy production and cellular function.
  • All-rac-alpha-tocopheryl acetate BP: A form of vitamin E, which acts as an antioxidant.
  • Thiamine Nitrate BP: A form of vitamin B1, essential for energy metabolism and nerve function.
  • Vitamin A BP: Important for vision, immune function, and skin health.
  • Ascorbic Acid BP: Also known as vitamin C, it’s a powerful antioxidant.
  • Pyridoxine Hydrochloride BP: A form of vitamin B6, involved in numerous bodily functions.

Dosage Information

The exact dosage of Calcium Pantothenate BP in Concavit Capsules is not specified in the provided information. However, the maximum daily dose of the product is listed as 3000 IU (International Units)[1]. It’s important to note that this refers to the total dosage of all ingredients, not just Calcium Pantothenate BP.

The maximum total dose amount over the course of treatment is listed as 3,285,000 IU, with a maximum treatment period of 36 months[1]. Always follow your healthcare provider’s instructions regarding dosage and duration of use.

Potential Side Effects

While the specific side effects of Calcium Pantothenate BP are not detailed in the provided information, vitamin supplements can sometimes cause mild side effects. These may include:

  • Nausea
  • Stomach discomfort
  • Headache

If you experience any unusual or severe side effects, contact your healthcare provider immediately.

Precautions and Considerations

Before taking Concavit Capsules or any supplement containing Calcium Pantothenate BP, consider the following:

  • Inform your healthcare provider about all medications and supplements you’re taking.
  • If you have any existing health conditions, especially those affecting nutrient absorption or metabolism, consult your doctor before use.
  • This product is not indicated as a pediatric formulation[1]. Consult a pediatrician before giving to children.
  • If you’re pregnant or breastfeeding, consult your healthcare provider before use.

Remember, while Calcium Pantothenate BP and other vitamins are essential for health, they should be taken as part of a balanced diet and healthy lifestyle. They are not intended to diagnose, treat, cure, or prevent any disease. Always consult with a healthcare professional for personalized advice.

Aspect Details
Study Type Open-label extension study
Main Objective Evaluate safety and tolerability of extended dosing with eplontersen in ATTR-CM patients
Secondary Objective Assess efficacy parameters in overall population and subgroups
Key Inclusion Criteria Completion of previous related study or satisfactory participation in specific ATTR-CM study
Key Exclusion Criteria Permanent discontinuation of study drug in previous study or unsuitable conditions for enrollment
Primary Endpoints Safety assessments, adverse events, anti-drug antibody assessments
Secondary Endpoints Biomarkers, clinical tests, imaging tests, quality of life assessments
Supplementary Treatment Concavit Capsules (containing Calcium Pantothenate BP and other vitamins)
Maximum Treatment Duration 36 months

FAQ

  • What is Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)? ATTR-CM is a rare heart condition where abnormal proteins called amyloids build up in the heart, affecting its function. This can lead to heart failure and other serious complications.
  • What is the main purpose of the clinical trial involving Calcium Pantothenate BP? The main purpose is to evaluate the long-term safety and effectiveness of eplontersen in treating ATTR-CM. Calcium Pantothenate BP, as part of Concavit Capsules, is used as a supplementary treatment in the trial.
  • Who is eligible to participate in this clinical trial? Eligible participants are those who have completed the treatment period and end-of-treatment visit in a previous related study, or have been diagnosed with ATTR-CM and participated satisfactorily in another specific study.
  • What are some of the tests and assessments performed during the trial? The trial includes various tests such as blood tests, physical examinations, electrocardiograms (ECGs), 6-minute walk tests, echocardiograms, and quality of life questionnaires to assess the treatment's effects and safety.
  • How long does the treatment in this trial last? The maximum treatment period mentioned in the trial information is 36 months, which is equivalent to 3 years.

Ongoing Clinical Trials on Calcium Pantothenate 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 rare heart condition where abnormal protein deposits (amyloids) build up in the heart, affecting its function and potentially leading to heart failure.
  • Eplontersen: The main drug being studied in this clinical trial for the treatment of ATTR-CM.
  • Calcium Pantothenate BP: A form of vitamin B5 that is one of the active ingredients in Concavit Capsules, used as a supplementary treatment 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.
  • Echocardiogram (ECHO): A test that uses sound waves to create images of the heart, allowing doctors to see its structure and function.
  • 6-minute walk test (6MWT): A test that measures the distance a person can walk in 6 minutes, used to assess functional capacity and exercise tolerance.
  • Quality of life questionnaires: Surveys that assess how a person's health condition affects their daily life and overall well-being.
  • Biomarkers: Measurable substances in the body that can indicate the presence or severity of a disease or the effects of a treatment.

References

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