Can extra calories help kids with heart disease grow stronger?
NCT ID NCT07552688
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether high-calorie diets and special nutritional formulas can help underweight children aged 1 to 5 with congenital heart disease gain weight. Seventy-five children will be split into three groups: standard diet, high-calorie diet, or high-calorie diet plus a special formula. Over 8 weeks, researchers will measure weight gain, appetite, and feeding tolerance to see which approach works best.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- High-calorie specialized nutritional formula and high-calorie diet
- What this could lead to
- If successful, this could provide a simple, effective way to help underweight children with congenital heart disease gain weight and improve their overall health.
- What could go wrong
- This is a small, early-stage trial with only 75 children, so results may not apply to all. The intervention is dietary, so benefits may be modest and depend on adherence.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 75 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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1 year to 5 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Children aged 1 to 5 years. * Diagnosed with congenital heart disease (confirmed by echocardiography). * Underweight (weight-for-age below the 10th percentile). * Medically stable and eligible for oral or enteral feeding. * Informed consent obtained from a parent. Exclusion Criteria: * Children with genetic syndromes known to affect growth (e.g., Down syndrome). * Children with gastrointestinal conditions impairing nutrient absorption. * Children who had cardiac surgery within the last 4 weeks. * Presence of severe organ failure (renal, hepatic, etc.). * Children on parenteral nutrition. * Families unlikely to adhere to follow-up or dietary instructions.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
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Locations
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Cardiac center Pediatric Cardiology Unit and Nutrition Clinic
Erbil, 44001, Iraq
Contact Email: •••••@•••••
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Pediatric Cardiology Unit, Cardiac Center
Erbil, 44001, Iraq
Contact Email: •••••@•••••
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