A low-intervention randomised, double-blind, placebo-controlled pilot trial evaluating the feasibility, tolerability and adherence of alternate-day oral Duroferon (ferrous sulphate) in adolescent girls with iron deficiency, and the diagnostic performance of the IRON-5 screening tool (IRONGIRLS-PILOT).
This research is looking into how well a common iron supplement called Duroferon works for teenage girls who have low iron levels. Instead of taking it every day, they'll take it every other day. We want to see how easy it is for girls to stick to this, if they can tolerate it, and if it helps. The study also tests a new screening tool called IRON-5 to see how accurately it can spot low iron levels. This is a small, early-stage study to find out if these approaches are practical and can be used in a larger trial later on. Participants will receive either the iron tablet or a dummy pill, without knowing which one they have.
At a glance
What is this study about?
This study is for teenage girls who have low iron, a common problem that can make you feel tired and weak. The main idea is to see if taking a common iron tablet, called Duroferon, every other day instead of every day is an effective and easy way to treat low iron. Sometimes, taking iron supplements can cause side effects like an upset stomach, so trying them less frequently might make them easier to take.
We also want to test a new questionnaire called IRON-5. This tool is designed to help doctors figure out if someone has low iron more easily. We'll be checking how accurate this questionnaire is compared to blood tests. The study is a "pilot" which means it's a small-scale trial to work out any problems and see if it's a good idea to do a bigger study later on.
Participants will be divided into two groups by chance: one group will get the Duroferon tablet, and the other will get a dummy pill (a placebo) that looks exactly the same but doesn't contain any medicine. Neither you nor your doctor will know which one you're taking until the study ends. This helps us get fair and unbiased results to understand the true effect of the iron tablets.
Key takeaways
- This study is for female young adults (aged 18 and over) with low iron.
- It tests an iron tablet (Duroferon) taken every other day.
- It also checks a new screening tool (IRON-5) for accuracy.
- Participants will receive either the iron tablet or a dummy pill.
- The goal is to find better ways to treat and identify iron deficiency.
- Your health will be closely monitored throughout the study.
Who may be eligible?
This study is specifically looking for young women who are 18 years old or older. The main condition for joining is that you have iron deficiency.
It's important to note that this study is only open to females. If you fall within this age range and have been told you have low iron, you might be a good fit for this research.
Before you can join, the study team will do some checks to make sure it's safe and appropriate for you. They will confirm your iron levels and go through your medical history.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Are you female?
- Have you been diagnosed with iron deficiency?
- Are you willing to take study medication every other day?
- Are you able to attend appointments for blood tests and check-ups?
What does participation involve?
If you decide to take part, you'll be involved in the study for a period of time, which will include some visits for check-ups and blood tests. You'll either receive the Duroferon iron tablet or a dummy pill, and you'll be asked to take it every other day. You won't know which one you're receiving.
During the study, you'll also be asked to answer questions related to your iron levels, fatigue, and general well-being. This will likely involve filling out questionnaires about your diet, how much you exercise, and your periods. There will be regular follow-up appointments to monitor your iron levels and other relevant health markers like Vitamin B12 and Vitamin D, usually through blood tests. The study will last long enough to see the effects of the treatment and gather all the necessary information.
Potential risks and benefits
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Common questions
What is 'iron deficiency'?
Iron deficiency means your body doesn't have enough iron, which can make you feel very tired, weak, and dizzy.
What is Duroferon?
Duroferon is a common iron supplement in tablet form that helps to increase iron levels in your body.
Why are you taking the tablets every other day?
We are testing if taking the iron tablets every other day is just as effective and causes fewer side effects than taking them daily.
What is a 'placebo'?
A placebo is a dummy pill that looks exactly like the real medicine but contains no active drug. It helps us see the true effect of the medicine.
What is IRON-5?
IRON-5 is a new questionnaire designed to help doctors quickly identify if someone might have low iron levels.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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