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The ketogenic diet therapy for children with global developmental delay

clinical study of the ketogenic diet for global developmental delay in children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-16009650
Enrollment
Unknown
Registered
2016-10-27
Start date
2016-11-15
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

global developmental delay in children

Interventions

2:ketogenic diet therapy

Sponsors

The Third Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 5 Years

Inclusion criteria

Inclusion criteria: 1. Pediatric patients with global developmental delay were recruited from June 2016 to December 2016 in the Third Affiliated Hospital of Zhengzhou University Department of rehabilitation of children with GDD, the symptoms of the patient meet the diagnostic criteria of DSM-5 made by American Psychiatric Association; 2. Aged between 6 months old and 5 years old; 3. DQ is less than or equal to 75 and the social life ability scale for children from the infants to middle school students is less than or equal to 8; 4. KD treatment has not been applied in the past 3 months; 5. Informed consent form has been signed when KD treatment is requested or accepted by the patient's parents, included in the study.

Exclusion criteria

Exclusion criteria: 1. Patients with fever or infectious disease of active phase; 2. patients with severe diseases in digestive system, cardiovascular system, respiratory system, urinary system or liver disease or metabolic disease who are not suitable for the research; patients with hyperemesis; 3. Patients with congenital immunodeficiency disease or contraindication for KD treatment.

Design outcomes

Primary

MeasureTime frame
Gesell Development Schedule Test;Social life ability scale for children from the infants to middle school students;The weight Z-score;The weight Z-score;Side-effect;

Countries

China

Contacts

Public ContactZHU Dengna

The Third Affiliated Hospital of Zhengzhou University

zhudengna@126.com+86 13838141626

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026