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Use of the Modified Atkins Diet in Infantile Spasms

NCT01006811 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2010-11-22

No results posted yet for this study

Summary

Infantile spasms constitute a type of catastrophic epilepsy syndrome occuring in young children. The ketogenic diet has been shown to be very effective in these children. The modified Atkins diet is a less restrictive option than the ketogenic diet, which has been effective in preliminary studies on refractory epilepsy in children, adolescents and adults. Modified Atkins diet may be of special importance in infants, as proteins are not restricted, hence no problems with growth are expected. Hence this pilot study has been planned to evaluate the efficacy and tolerability of the modified Atkins diet in infantile spasms refractory to conventional treatment (ACTH, vigabatrin, and anti-epileptic drugs).

Conditions

  • Infantile Spasms

Interventions

DIETARY_SUPPLEMENT

modified Atkins diet

Modified Atkins Diet administration 1. Carbohydrates intake restricted to 10 grams/ day. (Carbohydrate values of various food items will be explained in detail, and exchange lists provided. Four 2.5 grams carbohydrate exchange items will be allowed in a day.) 2. Fats (e.g. cream, butter, oils, ghee) encouraged. 3. Proteins (cheese, fish, eggs, chicken, soya products) unrestricted. 4. Clear carbohydrate-fluids not restricted. 5. Calcium and multivitamin supplementation will be provided.

OTHER

modified Atkins diet

Modified Atkins Diet administration 1. Carbohydrates intake restricted to 10 grams/ day. (Carbohydrate values of various food items will be explained in detail, and exchange lists provided. Four 2.5 grams carbohydrate exchange items will be allowed in a day.) 2. Fats (e.g. cream, butter, oils, ghee) encouraged. 3. Proteins (cheese, fish, eggs, chicken, soya products) unrestricted. 4. Clear carbohydrate-fluids not restricted. 5. Calcium and multivitamin supplementation will be provided.

Sponsors & Collaborators

  • All India Institute of Medical Sciences

    lead OTHER

Principal Investigators

  • Suvasini Sharma, MD, DM · All India Institute of Medical Sciences

  • Sheffali Gulati, MD · All India Institute of Medical Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-10-31
Completion
2010-11-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01006811 on ClinicalTrials.gov