Study of effectiveness of the modified Atkins diet in refractory childhood epilepsy

Phase 2

Completed

• Registration Number: CTRI/2009/091/000053
• Lead Sponsor: AIIMS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 96

Inclusion Criteria

1)Age: 2 ? 14 years.
2) Seizures persisting daily or more than 7 per week despite the appropriate use of at least 3 anti-epileptic drugs.

Exclusion Criteria

1)Known or suspected inborn error of metabolism:
Clinical suspicion of metabolic disorder as evidenced by 2 or more of the following- a history of parental consanguinity, prior affected siblings, unexplained vomiting, intermittent worsening of symptoms, recurrent episodes of lethargy, altered sensorium, or ataxia, hepatosplenomegaly on examination
With or without 2 or more of the following biochemical abnormalities
High blood ammonia (>80mmol/L), High arterial lactate (>2 mmol/L), metabolic acidosis (pH <7.2), hypoglycaemia (blood sugar <40 mg/dl), abnormal urinary aminoacidogram, presence of reducing sugars or ketones in urine, and positive results on urine neurometabolic screening tests.
2)Motivational or psychosocial issues in the family which would preclude compliance
3)Systemic illness- chronic hepatic, renal or pulmonary disease

Study & Design

• Study Type: Interventional
• Study Design: Not specified