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NCT00681239 · ClinicalTrials.gov registry record · Phase 3
Atkins Plus KetoCal for Childhood Epilepsy
A Phase 3 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 3
- Development phase
- 30
- Enrollment target
NCT00681239: Completed Phase 3 study, sponsored by Johns Hopkins University.
NCT00681239 is a Phase 3 study that has completed, run by Johns Hopkins University. The registered enrollment target is 30 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00681239, a Phase 3 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 30 participants
- Enrollment target
Study Summary
The modified Atkins diet (MAD) is a relatively new, alternative dietary therapy for intractable childhood and adult epilepsy. Recent evidence suggests that a strict, highly ketotic, first month may be advantageous to both immediate and long-term efficacy. KetoCal® is a pre-mixed powder that can be used to create a 4:1 ketogenic diet shake as a meal substitute. The investigators hypothesize that substituting KetoCal® for a lunch during the initial month of the MAD will lead to improved seizure reduction over the MAD alone, as well as improved tolerability and lipid values.
Interventions
- DIETARY_SUPPLEMENT Modified Atkins diet and KetoCal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2008-05 |
| Est. Completion | 2009-12 |
| Phase | Phase 3 |
What the finished NCT00681239 record still lists
NCT00681239 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Modified Atkins diet and KetoCal is the first listed.
NCT00681239 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00681239 about?
NCT00681239 is a clinical study titled "Atkins Plus KetoCal for Childhood Epilepsy". The modified Atkins diet (MAD) is a relatively new, alternative dietary therapy for intractable childhood and adult epilepsy. Recent evidence suggests that a strict, highly ketotic, first month may be advantageous to both immediate and long-term efficacy. KetoCal® is a pre-mixed powder that can be u...
What is the current status of trial NCT00681239?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 30 participants. The study started on 2008-05. Estimated completion is 2009-12.
What interventions are being tested in trial NCT00681239?
The interventions under investigation include: Modified Atkins diet and KetoCal (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00681239?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00681239's enrollment target sits among peer trials
30 1917th of 2000 higher than 68 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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