AuthorisedTherapeutic use (Phase IV)Interventional

DonneDVit : Assessing the Impact of a Mode of Vitamin D Supplementation (Sequential Dose vs Daily Dose) on the Incidence of Hypercalciuria in Subjets Aged From 2 to 18 Years. Randomized controlled trial with 2 parallel groups.

This study, called DonneDVit, is looking into how two different ways of giving vitamin D supplements affect calcium levels in the urine of children and teenagers aged 2 to 18 years old. Vitamin D is important for healthy bones, but sometimes too much calcium can build up in the urine (this is called hypercalciuria). The researchers want to compare giving vitamin D every day versus giving larger doses less often, to see which method is less likely to cause high calcium levels in the urine. They will measure calcium in urine samples over a few weeks to find this out. This is a "Phase IV" study, meaning the medicines are already approved for use, and the study is gathering more information on their safety and best use.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Centre Hospitalier Universitaire De Montpellier

Enrolment target

280

Start

15 Nov 2024

Transient hypercalciuria

What is this study about?

This study, known as DonneDVit, is designed to understand the best way to give vitamin D supplements to children and teenagers aged between 2 and 18 years old. Vitamin D is really important for building strong bones and overall health. However, in some children, giving vitamin D can sometimes lead to a temporary condition where there's too much calcium in their urine. This is called 'transient hypercalciuria'. While often harmless, it's something doctors want to understand better to prevent any potential issues.

Researchers are comparing two common ways of taking vitamin D: either a small dose every day, or a larger dose taken less frequently (like once a month or every few months). Both types of vitamin D supplements used in this study are already approved medicines. The main goal is to see which way of giving vitamin D is less likely to cause these temporary high calcium levels in the urine. They are also looking at whether tiny calcium crystals form in the urine, and generally how well children tolerate the treatments.

Understanding how different dosing methods affect calcium levels in urine is important for doctors to recommend the safest and most effective way to give vitamin D to children. This study helps improve how we use medicines that are already available, making sure children get the benefits of vitamin D without unnecessary side effects.

Key takeaways

This study compares two ways to give vitamin D to children aged 2-18.
It aims to find out which method lessens too much calcium in urine.
Participation involves taking vitamin D and collecting morning urine samples over 28 days.
The vitamin D products studied are already approved and widely used.
Results could help doctors give vitamin D more safely and effectively.

Who may be eligible?

This study is looking for children and teenagers who are currently between 2 and 18 years old.

Both boys and girls can take part. To join, a child would need to have been diagnosed with 'transient hypercalciuria'. This means they have had a temporary condition where there was too much calcium in their urine, but it wasn't due to a long-term kidney problem or another serious illness.

There will be other specific health requirements that the study doctors will check to make sure it's safe for your child to participate. Your child's doctor or the study team can explain these in detail.

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.

Is your child between 2 and 18 years old?
Has your child been diagnosed with 'transient hypercalciuria' (too much calcium in urine, but temporary)?
Is your child able to provide a first morning urine sample?
Are you able to attend appointments and collect samples as required by the study?

Answer every question to see your result.

What does participation involve?

If your child takes part in this study, they will be given vitamin D supplements in one of two ways: either a daily dose or a less frequent, larger dose. Which one they receive will be decided by chance, like flipping a coin. Over a month, there will be a few key check-ups.

You'll need to collect your child's first morning urine sample on day 7, day 14, and day 28 of the study. These samples will be checked for calcium levels and to see if any tiny calcium crystals are forming. The study team will also keep a close eye on your child for any side effects or discomfort they might experience during this time. The total duration of active participation will be around 28 days.

Potential risks and benefits

Taking part in this study could help doctors learn more about the best way to give vitamin D to children, potentially improving care for many young people in the future. As with any medication, there's always a small chance of side effects, even though the vitamin D used here is already approved. The study team will carefully monitor your child for any expected or unexpected reactions. Remember, taking part is completely voluntary, and you are free to withdraw your child from the study at any time without it affecting their usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is 'transient hypercalciuria'?

It means there's temporarily too much calcium in your child's urine. It's often not serious but needs to be monitored.

What kind of vitamin D medicines are being used?

The study uses two types of vitamin D medicines (ADRIGYL and UVEDOSE) that are already approved for use in the UK.

Will my child know which vitamin D they are getting?

No, it's a 'randomised controlled trial' so your child will be assigned to either the daily or less frequent dose by chance, and usually, neither you nor the doctors will know which one until the study is over, to keep the results fair.

How long will my child be in the study?

Your child's active participation will last for about 28 days, primarily involving collecting urine samples and reporting any side effects.

Why are urine samples collected in the morning?

First morning urine samples are usually the most concentrated, giving a clearer picture of what's happening in the body without being affected by drinks or food during the day.