PedMIDAS: development of a questionnaire to assess disability of migraines in children.
A D Hershey, S W Powers, A L Vockell...
https://pubmed.ncbi.nlm.nih.gov/11739822/Actively Recruiting
Led by Danone Nutricia SpA Società Benefit · Updated on 2025-09-03
100
Participants Needed
3
Research Sites
52 weeks
Total Duration
This research aims to learn about the clinical and nutritional effects of the ketogenic diet KD in children with genetic, neurological, or metabolic conditions that require this diet. The study focuses on whether KD supports proper growth, improves clinical symptoms, and impacts quality of life. It involves pediatric patients, including those with drug-resistant epilepsy and other neurological or metabolic diseases, to explore these areas more comprehensively. Participants receive a ketogenic diet as part of their clinical care. The specific prescription, type of KD protocol, and how it is administered depend on each childs ability to feed independently, their willingness, and the severity of their condition. This is an observational study, so treatments are given according to usual clinical practice, and the study follows patients over time to observe outcomes. During the study, participants will be monitored through regular clinical visits that assess nutritional adequacy, such as growth, lipid profiles, vitamin intake, and bone mineral density. Quality of life will be evaluated using parent questionnaires. The main outcome is nutritional adequacy measured at six months, with optional assessments at 12 months. Participants are followed as per normal clinical practice, with no experimental treatments assigned, allowing researchers to gather real-world information about KDs effects in this group.
CONDITIONS
Effectiveness and Impact on the Quality of Life of Ketogenic Diet in Pediatric Patients
A
Antonella Diamanti, MD
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Danone Nutricia SpA Società Benefit
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months (12 months optional)
Participants who undergo routine ketogenic diet therapy as per clinical practice are observed for nutritional adequacy and health-related quality of life impacts.
Regular visits according to clinical practice
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Lead Sponsor