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Comparison of two high fat, low carbohydrate diets in controlling infantile spasms in children who do not respond to conventional medicines

Modified Atkins diet versus Ketogenic diet in the management of Infantile spasm refractory to first line treatment in children aged 9 months-5 years: A Randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/03/023791
Enrollment
40
Registered
2020-03-05
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: G403- Generalized idiopathic epilepsy and epileptic syndromes

Interventions

Intervention1: Modified Atkins diet: In the Modified Atkins diet, patients limit their daily intake of net carbohydrates to 10-20 g/day Control Intervention1: Ketogenic Diet: The diet is started with

Sponsors

Jaya Shankar Kaushik
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 9 months to 5 years with Infantile spasm refractory to first line treatment.

Exclusion criteria

Exclusion criteria: (i) Children with known or suspected inborn error of metabolism. (ii) Children with systemic illness-renal, pulmonary, cardiac or hepatic dysfunction. (iii) Severe malnutrition (weight for length and height for age less than 3 SD for mean as per WHO growth charts). (iv) Motivational and psychosocial issues in the family which could possibly affect the compliance.

Design outcomes

Primary

MeasureTime frame
Proportion of children who achieved seizure freedom as per parental reports at 4 weeks and 12 weeks in both the groups.Timepoint: Proportion of children who achieved seizure freedom as per parental reports at 4 weeks and 12 weeks in both the groups.

Secondary

MeasureTime frame
a. Proportion of children who achieved 50 percent reduction in seizure as per parental reports at 4 weeks and 12 weeks in both the groups. b. Proportion of children who achieve resolution of Hypsarrhythmia. c. Description and proportion of the adverse effects of the diet as per parental reports. Timepoint: 4 weeks 12 weeks

Countries

India

Contacts

Public ContactShobhna Sharma

Pt. B.D. Sharma PGIMS Rohtak

jayashankarkaushik@gmail.com9871174069

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 11, 2026