Efficacy and tolerance of nicotinamide supplementation during acute kidney injury: a prospective randomized double-blind trial
This medical study, called a Phase III trial, is looking into whether a vitamin called nicotinamide can help people recover from a sudden and severe kidney problem known as acute kidney injury. When someone has acute kidney injury, their kidneys stop working well very quickly. In this study, some people will be given nicotinamide, while others will receive a dummy pill (which looks the same but contains no active medicine). Doctors will then check 21 days later to see if taking nicotinamide improves how well the kidneys are working. The main goal is to find out if more people who take nicotinamide have their kidney function return to normal compared to those who don't. This research helps us understand better ways to treat acute kidney injury.
At a glance
What is this study about?
This study is a research project focusing on a condition called 'acute kidney injury'. This happens when your kidneys, which usually filter your blood, suddenly stop working properly. It can be a very serious condition. Doctors are trying to find the best ways to help people recover from this.
In this study, they are testing a common vitamin called nicotinamide. You might know it as a form of Vitamin B3. The aim is to see if giving people nicotinamide when they have acute kidney injury can help their kidneys recover faster and better. Half of the people in the study will be given nicotinamide, and the other half will get a 'dummy' pill that looks identical but has no medicine in it. This is a common way to test new treatments fairly.
The main thing the doctors will be looking at is how well your kidneys are working 21 days after you start the treatment. They will measure your 'eGFR', which is a way to estimate how well your kidneys are filtering. If your kidneys return to working normally or close to normally, then the treatment will be considered a success. This study is important because if nicotinamide helps, it could become a new way to treat acute kidney injury and improve people's chances of a full recovery.
Key takeaways
- The study is investigating a common vitamin, nicotinamide, for acute kidney injury.
- It's a 'Phase III' study, meaning it's a key stage of testing a potential new treatment.
- Participants will be randomly given either nicotinamide or a dummy pill.
- The main goal is to see if kidney function improves after 21 days.
- Your kidney function (eGFR) will be carefully monitored.
- Taking part helps research to find better treatments for acute kidney injury.
Who may be eligible?
To be considered for this study, you would need to be 18 years old or older. The study is open to both men and women.
The most important thing is that you would need to have been recently diagnosed with acute kidney injury. This means your kidneys have suddenly stopped working as well as they should.
The research team will have other specific medical criteria to make sure the study is safe and effective for everyone involved. They will check your medical history and current health carefully to see if you are a good fit for this particular study. Only your doctor and the study team can confirm if you meet all the requirements.
- Are you 18 years old or older?
- Have you recently been diagnosed with acute kidney injury?
- Are you willing to potentially receive a dummy pill instead of the active medicine?
- Can you attend regular hospital/clinic visits for assessments?
- Are you able to take study medication as prescribed?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you would be randomly assigned to either receive the nicotinamide medicine or a dummy pill (placebo) that looks the same. You wouldn't know which one you're getting, and neither would your doctors, to keep the study fair. You would take this medication for a set period.
Over the course of the study, you would have regular visits to the hospital or clinic. During these visits, doctors would assess your health, conduct blood tests (to check your kidney function), and ask about any symptoms or side effects you might be experiencing. The main assessment of your kidney recovery would happen 21 days after you start the treatment.
The total duration of your participation in the study would involve taking the medication and having follow-up assessments over several weeks, specifically focusing on the 21-day mark for recovery assessment. Further follow-up might be required.
Potential risks and benefits
Locations (1)
- —France
Common questions
What is 'acute kidney injury'?
Acute kidney injury is when your kidneys suddenly stop working as well as they should. It's a serious condition that needs urgent medical attention.
What is nicotinamide?
Nicotinamide is a form of Vitamin B3. It's a common vitamin that's available as a supplement.
Will I know if I'm getting the real medicine or a dummy pill?
No, neither you nor your doctors will know if you're getting the nicotinamide or the dummy pill. This is done to make sure the study results are fair and accurate.
How long will I be in the study?
The main part of the study involves taking the treatment and having your kidney function checked 21 days later. There might be further follow-up appointments after that.
What does 'eGFR' mean?
eGFR stands for 'estimated glomerular filtration rate'. It's a number that doctors use to estimate how well your kidneys are filtering waste from your blood.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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