#1 Clinical Trials Search in Europe

Pyridoxine Hydrochloride Bp

This article discusses the use of Pyridoxine Hydrochloride BP, a form of vitamin B6, in clinical trials as part of a multivitamin formulation. While the primary focus of the trial is on a different drug (eplontersen) for treating transthyretin-mediated amyloid cardiomyopathy (ATTR-CM), the multivitamin containing Pyridoxine Hydrochloride BP is mentioned as a supplementary treatment. This information provides insights into how vitamin B6 may play a role in supporting cardiovascular health in patients with specific heart conditions.

Table of Contents

What is Pyridoxine Hydrochloride BP?

Pyridoxine Hydrochloride BP, also known as Vitamin B6, is an essential vitamin that plays a crucial role in various bodily functions[1]. The “BP” in its name stands for “British Pharmacopoeia,” which indicates that it meets specific quality standards[1]. This vitamin is water-soluble, meaning that it dissolves in water and is not stored in the body for long periods, so it needs to be consumed regularly through diet or supplements.

Medical Uses

While the clinical trial data provided doesn’t specifically focus on Pyridoxine Hydrochloride BP, it is an important component of the multivitamin supplement called Concavit Capsules[1]. Pyridoxine Hydrochloride BP is known to have several health benefits and medical uses, including:

  • Supporting the nervous system function
  • Aiding in the formation of red blood cells
  • Helping the body metabolize proteins, fats, and carbohydrates
  • Supporting immune system function
  • Potentially helping to reduce symptoms of certain conditions, such as morning sickness in pregnancy (under medical supervision)

Administration

According to the information provided, Pyridoxine Hydrochloride BP is administered as part of Concavit Capsules, which are taken orally[1]. The capsules are described as soft capsules, which are typically easier to swallow than hard tablets.

Other Ingredients in Concavit Capsules

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

  • Ergocalciferol BP (Vitamin D2): Helps in calcium absorption and bone health
  • Nicotinamide BP (Vitamin B3): Important for cellular energy production
  • Riboflavin BP (Vitamin B2): Aids in energy production and cellular function
  • All-rac-alpha-tocopheryl acetate BP (Vitamin E): An antioxidant that protects cells from damage
  • Calcium Pantothenate BP (Vitamin B5): Helps in energy production and hormone synthesis
  • Thiamine Nitrate BP (Vitamin B1): Important for energy metabolism and nerve function
  • Vitamin A BP: Essential for vision, immune function, and cell growth
  • Ascorbic Acid BP (Vitamin C): An antioxidant important for immune function and skin health

Dosage Information

The clinical trial data provides some general dosage information for Concavit Capsules, which contains Pyridoxine Hydrochloride BP[1]:

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

It’s important to note that this dosage information is for the entire multivitamin supplement, not just for Pyridoxine Hydrochloride BP. Always follow your healthcare provider’s instructions regarding dosage and duration of use.

Safety Considerations

While the provided clinical trial data doesn’t specifically address the safety of Pyridoxine Hydrochloride BP, it’s important to consider the following general safety points when taking any vitamin supplement:

  • Always consult with your healthcare provider before starting any new supplement regimen
  • Follow the recommended dosage instructions carefully
  • Be aware of potential interactions with other medications you may be taking
  • Report any unusual symptoms or side effects to your healthcare provider promptly
  • Keep supplements out of reach of children

Remember, while vitamins are essential for health, more is not always better. Excessive intake of certain vitamins can lead to adverse effects. Always use supplements under medical supervision, especially if you have any existing health conditions or are pregnant or breastfeeding.

Aspect Details
Main Drug Studied Eplontersen
Condition Studied Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)
Multivitamin Product Concavit Capsules
Pyridoxine Hydrochloride BP Role Component of multivitamin formulation
Other Vitamins Included Vitamins A, B1, B2, B3, B5, C, D2, E
Maximum Daily Dose 3000 IU
Maximum Total Dose 3,285,000 IU
Maximum Treatment Period 36 months
Administration Route Oral use
Study Type Open-Label Extension Study

FAQ

  • What is Pyridoxine Hydrochloride BP? Pyridoxine Hydrochloride BP is a form of vitamin B6, an essential nutrient that plays a role in various bodily functions, including metabolism and nervous system health. In this clinical trial, it is part of a multivitamin formulation.
  • How is Pyridoxine Hydrochloride BP used in the clinical trial? Pyridoxine Hydrochloride BP is used as part of a multivitamin formulation called Concavit Capsules. While not the main focus of the trial, it is mentioned as a supplementary treatment alongside the primary drug being studied for transthyretin-mediated amyloid cardiomyopathy (ATTR-CM).
  • What is the main condition being studied in this clinical trial? The main condition being studied is transthyretin-mediated amyloid cardiomyopathy (ATTR-CM), a type of heart disease caused by the buildup of abnormal proteins in the heart muscle.
  • What other vitamins are included in the Concavit Capsules? The Concavit Capsules contain several vitamins and nutrients, including ergocalciferol (vitamin D2), nicotinamide (vitamin B3), riboflavin (vitamin B2), alpha-tocopheryl acetate (vitamin E), calcium pantothenate (vitamin B5), thiamine nitrate (vitamin B1), vitamin A, and ascorbic acid (vitamin C), in addition to pyridoxine hydrochloride (vitamin B6).
  • What is the maximum daily dose of the multivitamin in the trial? The maximum daily dose of the multivitamin formulation is 3000 IU (international units), with a maximum total dose amount of 3,285,000 IU over a maximum treatment period of 36 months.

Ongoing Clinical Trials on Pyridoxine Hydrochloride 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

  • Pyridoxine Hydrochloride BP: A form of vitamin B6, an essential nutrient important for metabolism, nervous system function, and the production of red blood cells.
  • Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM): A heart disease caused by the buildup of abnormal protein deposits (amyloids) in the heart muscle, affecting its function.
  • Eplontersen: The primary drug being studied in the clinical trial for the treatment of ATTR-CM.
  • Multivitamin: A supplement containing multiple vitamins and sometimes minerals, designed to provide essential nutrients that may be missing from a person's diet.
  • International Unit (IU): A measurement used for the amount of a substance based on its biological activity or effect.
  • 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.
  • Efficacy: The ability of a treatment to produce the desired beneficial effect.
  • Biomarker: A measurable indicator of a biological state or condition, often used to track the progress of a disease or the effects of treatment.
  • Echocardiogram (ECHO): A test that uses sound waves to create images of the heart, allowing doctors to see its structure and how well it's functioning.
  • Quality of Life (QoL): A measure of an individual's well-being and ability to perform daily activities, often assessed in clinical trials to determine the impact of a treatment on patients' lives.

References

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