Infantile SpasmsPhase 2/3ADISNCT01006811
Use of the Modified Atkins Diet in Infantile Spasms
A Phase 2/3 study testing modified Atkins diet in people with Infantile Spasms, run by All India Institute of Medical Sciences at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 months to 3 years
- Conditions the study is for
- Infantile Spasms
- What is being tested?
- modified Atkins diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteIndia
- Study dates
- Oct 2009to Nov 2010
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110049
About this study
Official title: Efficacy and Tolerability of the Modified Atkins Diet in Patients With Infantile Spasms: a Pilot Study.
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
- Being tested
- modified Atkins diet
- Keywords
- West syndrome, Hypsarrhythmia
- Medical subject headings
- Spasms, Infantile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified Atkins dietDietary supplement
Also called Dietary treatment
Modified Atkins Diet administration
- 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.)
- Fats (e.g. cream, butter, oils, ghee) encouraged.
- Proteins (cheese, fish, eggs, chicken, soya products) unrestricted.
- Clear carbohydrate-fluids not restricted.
- Calcium and multivitamin supplementation will be provided.
modified Atkins dietOther
Also called Dietary treatment
Modified Atkins Diet administration
- 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.)
- Fats (e.g. cream, butter, oils, ghee) encouraged.
- Proteins (cheese, fish, eggs, chicken, soya products) unrestricted.
- Clear carbohydrate-fluids not restricted.
- Calcium and multivitamin supplementation will be provided.
| Study group | Role | What they receive |
|---|---|---|
| modified Atkins diet | Experimental | Not described Receives: Dietary Supplement: modified Atkins diet; Other: modified Atkins diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
seizure reduction as per parental reports
seizure control at the end of 3 months will be classified as: spasm free; > 50% reduction in spasms; and < 50% reduction in spasms
Measured: 3 months
Secondary outcomes (1)
adverse effects of the diet as per parental reports
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionOct 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infantile SpasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Suvasini Sharma, MD, DM, Principal investigator, All India Institute of Medical SciencesSheffali Gulati, MD, Study director, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01006811
- Sponsor's protocol ID
- ADIS
- Acronym
- ADIS
- Status last verified
- Nov 2010
- First submitted
- 1 Nov 2009
- Last updated
- 22 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sharma S, Sankhyan N, Gulati S, Agarwala A. Use of the modified Atkins diet in infantile spasms refractory to first-line treatment. Seizure. 2012 Jan;21(1):45-8. doi: 10.1016/j.seizure.2011.08.009. Epub 2011 Sep 14.
PubMed 21920781
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerability of the Modified Atkins Diet in Patients With Infantile Spasms: a Pilot Study.
- ClinicalTrials.gov ID
- NCT01006811
- Acronym / sponsor ID
- ADIS / ADIS
- Conditions
- Infantile Spasms
- Keywords
- West syndrome, Hypsarrhythmia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 3 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| modified Atkins diet | Experimental | Dietary Supplement: modified Atkins diet, Other: modified Atkins diet |
Who may qualify
- Ages
- 6 months to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| modified Atkins dietAlso: Dietary treatmentModified 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. | Dietary supplement | modified Atkins diet |
| modified Atkins dietAlso: Dietary treatmentModified 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 |
Primary outcome
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
1 secondary outcome
adverse effects of the diet as per parental reports
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2010.
- Derived from this study: PubMed 21920781Sharma S, Sankhyan N, Gulati S, Agarwala A. Use of the modified Atkins diet in infantile spasms refractory to first-line treatment. Seizure. 2012 Jan;21(1):45-8. doi: 10.1016/j.seizure.2011.08.009. Epub 2011 Sep 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suvasini Sharma, MD, DM principal investigator
All India Institute of Medical Sciences
Sheffali Gulati, MD study director
All India Institute of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing modified Atkins diet in people with Infantile Spasms, run by All India Institute of Medical Sciences at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
seizure reduction as per parental reports (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01006811, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2010.