NCT01006811

Use of the Modified Atkins Diet in Infantile Spasms

Efficacy and Tolerability of the Modified Atkins Diet in Patients With Infantile Spasms: a Pilot Study.

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: All India Institute of Medical Sciences · Academic / Other
• Sex: All
• Age: 6 Months – 3 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-10-01
• Completion: 2010-11-01
• First posted: 2009-11-03
• Last updated: 2010-11-22

Locations

1 site across 1 country: India