Not yet recruitingEARLY_PHASE1INTERVENTIONAL

Effects of Iron Supplementation on Skeletal Muscle Properties in Females With Suboptimal Iron Storage

This study is investigating if taking iron supplements helps build iron stores in muscles and improves exercise ability in women aged 18-40 who have low iron levels. Some women will take an iron supplement, others a dummy pill, and a third group with normal iron levels will be observed. Researchers will measure iron levels in blood and muscle, and check how well participants can exercise. The goal is to understand if extra iron helps muscles work better, especially since many women have low iron, which can affect energy and performance.

At a glance

Status

Not yet recruiting

Phase

EARLY_PHASE1

Sponsor

University of Calgary

Enrolment target

Start

01 Aug 2025

Estimated completion

01 Jun 2026

Iron Deficiency

What is this study about?

This study wants to find out if taking iron supplements can increase the amount of iron stored in muscles and make exercise easier for women aged 18 to 40 who have low iron levels. We know that iron is really important for muscles to work properly, helping them get oxygen, produce energy, and recover after exercise. Many women, especially those who are active, often have too little iron in their bodies.

Even though we know muscles store some iron, we're not sure if taking extra iron will actually lead to noticeable changes in these muscle stores or if it will make a difference to how well you can exercise. This research aims to answer those questions. If a simple iron supplement can improve muscle function, it could be very helpful for many women.

The study will compare women with low iron who take a real iron supplement to those who take a 'dummy' pill (called a placebo). We'll also look at a group of women who already have normal iron levels to understand the natural differences. By doing this, we hope to learn if boosting your iron can truly help your muscles.

Key takeaways

Study for women aged 18-40 focusing on low iron.
Aims to see if iron supplements boost muscle iron and exercise ability.
Involves taking iron or a dummy pill for 12 weeks, or being a comparison group.
Includes blood tests, muscle samples, and exercise tests.
Could help understand how iron impacts muscle health in women.

Who may be eligible?

The study is looking for women between 18 and 40 years old. You might be suitable if you have lower than normal iron levels in your blood. There's also a group for women with normal iron levels to help with comparisons.

However, you won't be able to join if you are overweight (BMI over 30), or if you have certain health conditions like heart, lung, kidney, or gut problems, or diabetes. You also can't take part if you are taking medications that affect your heart, breathing, or metabolism, or if you regularly take strong painkillers like anti-inflammatories. If you've recently given blood, had surgery, or taken certain antibiotics, that would also exclude you.

Other reasons you might not be able to join include if you are pregnant or planning to be, smoke, drink a lot of alcohol, currently take iron supplements, or are on certain diets known to affect iron levels. It's important to be healthy overall and able to do exercise.

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 a woman between 18 and 40 years old?
Do you think your iron levels might be a bit low (or you have normal levels)?
Are you generally healthy and able to exercise?
Are you not pregnant or planning to be during the study?
Are you not taking medications that might interfere with the study, and you don't smoke or drink heavily?

Answer every question to see your result.

What does participation involve?

If you join, you'll be randomly put into one of three groups. If you have low iron, you'll either take a 150mg iron supplement or a dummy pill every other day for 12 weeks. If you have normal iron, you'll be part of a comparison group and won't take a supplement.

Before and after the 12 weeks, you'll have some tests. These include blood tests to check your iron, small muscle samples (biopsies) from your leg to look at muscle iron, and exercise tests on your whole body and one leg to see how well you perform. If you're in the group with normal iron, you'll only have these tests at the beginning. The total duration of active participation for the iron-taking groups would be about 12 weeks plus the testing appointments.

Potential risks and benefits

Participating in this study might help us understand more about how iron affects muscles, which could benefit women in the future. However, there are potential risks, such as discomfort from blood tests and muscle biopsies, or possible upset stomachs from the iron supplements. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

University of Calgary
Verified postcode
Calgary, Canada

Common questions

What is 'suboptimal iron storage'?

This means your body has lower iron levels than ideal, but you might not necessarily have full-blown anaemia (very low red blood cells).

What is a placebo?

A placebo is a 'dummy' pill that looks like the real iron supplement but contains no active ingredient, like a sugar pill. It helps us see if the real medicine is having an effect.

What is a 'skeletal muscle biopsy'?

This is a minor procedure where a very small piece of muscle is taken from your leg to look at it closely in a lab.

How long will I be in the study?

If you take a supplement or placebo, you'll be in the study for about 12 weeks, plus initial and final testing appointments. If you're a control, you'll only have baseline tests.

Will I know if I'm taking the iron supplement or the dummy pill?

No, you won't know, and neither will the researchers. This is called 'blinding' and helps ensure the results are unbiased.

How to find out more

Alexander L Isidori

alex.isidori1@ucalgary.ca 6475173560 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.