Sharma 2013.
Methods | Open‐label, single‐centre, parallel‐group, randomised controlled trial, to compare the MAD to a control group over a 3‐month period. Authors noted the study design to be similar to that of Neal 2008. There was a 4‐week baseline of seizure frequency. | |
Participants | 102 children aged 2‐14 years with drug‐resistant epilepsy and 2‐14 daily seizures, having previously tried 3 AEDs. Study conducted in India | |
Interventions | Randomised into 1 of 2 groups; MAD (50 participants) or a normal diet (52 participants) for a period of 3 months | |
Outcomes |
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Notes | 4 children reported to have dropped out of the trial. 2 secondary to lower respiratory tract infections, 1 secondary to hyperammonaemic encephalopathy and 1 as the child and family found the diet too restrictive. In the control group, 3 participants were lost to follow‐up. Exclusion criteria: known or suspected inborn errors of metabolism, systemic illness or motivational issues the family that would prelude compliance. The lead author (Sharma) was financially supported as a Senior Research Associate in the “Scientists pool scheme” of the Council for Scientific and Industrial Research (CSIR), Government. of India, for this study. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation sequence was computer generated |
Allocation concealment (selection bias) | Low risk | Opaque sealed envelopes were used to conceal allocation. |
Blinding (performance bias and detection bias) All outcomes | High risk | Unblinded |
Incomplete outcome data (attrition bias) | Low risk | Study attrition reported an ITT analysis carried out |
Selective reporting (reporting bias) | Low risk | Protocol available 15 August 2015 (clinicaltrials.gov/ct2/show/NCT00836836; Sharma 2009) |
Other bias | High risk | Excluded participants where motivational issues within the family were noted |