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Use of the Modified Atkins Diet in Infantile Spasms (ADIS)
This study has been completed.
Sponsor:
All India Institute of Medical Sciences, New Delhi
Information provided by:
All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT01006811
First received: November 1, 2009
Last updated: November 19, 2010
Last verified: November 2010
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
| Infantile Spasms | Dietary Supplement: modified Atkins diet Other: modified Atkins diet | Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | Efficacy and Tolerability of the Modified Atkins Diet in Patients With Infantile Spasms: a Pilot Study. |
Resource links provided by NLM:
Genetics Home Reference related topics:
X-linked infantile spasm syndrome
MedlinePlus related topics:
Muscle Cramps
U.S. FDA Resources
Further study details as provided by All India Institute of Medical Sciences, New Delhi:
Primary Outcome Measures:
- seizure reduction as per parental reports [ Time Frame: 3 months ]seizure control at the end of 3 months will be classified as: spasm free; > 50% reduction in spasms; and < 50% reduction in spasms
Secondary Outcome Measures:
- adverse effects of the diet as per parental reports [ Time Frame: 3 months ]
| Estimated Enrollment: | 15 |
| Study Start Date: | October 2009 |
| Study Completion Date: | November 2010 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: modified Atkins diet |
Dietary Supplement: modified Atkins diet
Modified Atkins Diet administration
Other Name: Dietary treatment
Other: modified Atkins diet
Modified Atkins Diet administration
Other Name: Dietary treatment
|
Eligibility| Ages Eligible for Study: | 6 Months to 3 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age: 6 months to 3 years.
- Presence of epileptic spasms in clusters, with electroencephalographic evidence of hypsarrhythmia or its variants), having at least one cluster per day.
- Treatment with at least corticosteroid/ ACTH or Vigabatrin and one other AED( sodium valproate, pyridoxine, topiramate, zonisamide, benzodiazepines (clobazam, clonazepam, nitrazepam).
Exclusion Criteria:
- Known or suspected inborn error of metabolism, as evidenced by: 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 And/ or 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.
- Motivational or psychosocial issues in the family which would preclude compliance
- Systemic illness- chronic hepatic, cardiac, renal or pulmonary disease
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01006811
Please refer to this study by its ClinicalTrials.gov identifier: NCT01006811
Locations
| India | |
| All India Institute of Medical Sciences | |
| New Delhi, Delhi, India, 110049 | |
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Investigators
| Principal Investigator: | Suvasini Sharma, MD, DM | All India Institute of Medical Sciences, New Delhi |
| Study Director: | Sheffali Gulati, MD | All India Institute of Medical Sciences, New Delhi |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dr Suvasini Sharma, All India Institute of Medical Sciences |
| ClinicalTrials.gov Identifier: | NCT01006811 History of Changes |
| Other Study ID Numbers: |
ADIS |
| Study First Received: | November 1, 2009 |
| Last Updated: | November 19, 2010 |
Keywords provided by All India Institute of Medical Sciences, New Delhi:
|
West syndrome Hypsarrhythmia |
Additional relevant MeSH terms:
|
Spasm Spasms, Infantile Neuromuscular Manifestations Neurologic Manifestations Nervous System Diseases |
Signs and Symptoms Epilepsy, Generalized Epilepsy Brain Diseases Central Nervous System Diseases |
ClinicalTrials.gov processed this record on August 18, 2017