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NCT01953757 · ClinicalTrials.gov registry record · NA
A Nutritional Intervention for Diabetic Neuropathy (WCCR-DN2)
A NA study, sponsored by Physicians Committee for Responsible Medicine.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT01953757: Completed NA study, sponsored by Physicians Committee for Responsible Medicine.
NCT01953757 is a NA study that has completed, run by Physicians Committee for Responsible Medicine. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01953757, a NA study, has completed, sponsored by Physicians Committee for Responsible Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study Summary
The purpose of this study is to assess whether, in individuals with diabetic neuropathy, a low-fat, vegan diet in combination with a vitamin B12 supplement improves pain, sensation and other subjective symptoms, more effectively than a vitamin B12 supplement with no diet changes. The principal measure is pain as measured by the following assessment tools: Michigan Neuropathy Screening Instrument, Norfolk Quality of Life Questionnaire, Neuropathy Impairment Score - Lower Limbs, Neuropathy Total Symptom Score, Neuropathy Pain Scale, McGill Pain Questionnaire and Global Impression Scale. The study duration is 20 weeks. This study also examines the effects of a low-fat, vegan diet on mood, using the Center for Epidemiologic Studies Depression Scale-Revised, and the Beck Depression Inventory.
Primary Outcome
Pain will be measured follow the baseline and 20 week score using the following assessment tools: Michigan Neuropathy Screening Instrument Norfolk Quality of Life Questionnaire Neuropathy Impairment Score - Lower Limbs Neuropathy Total Symptom Score 6 Neuropathy Pain Scale McGill Pain Questionnaire Global Impression Scale
Interventions
- OTHER Vegan diet and vitamin B12 supplement
- DIETARY_SUPPLEMENT Vitamin B12 supplement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2013-09 |
| Est. Completion | 2015-03 |
| Phase | NA |
What the finished NCT01953757 record still lists
NCT01953757 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Vegan diet and vitamin B12 supplement is the first listed.
NCT01953757 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01953757 about?
NCT01953757 is a clinical study titled "A Nutritional Intervention for Diabetic Neuropathy (WCCR-DN2)". The purpose of this study is to assess whether, in individuals with diabetic neuropathy, a low-fat, vegan diet in combination with a vitamin B12 supplement improves pain, sensation and other subjective symptoms, more effectively than a vitamin B12 supplement with no diet changes. The principal measu...
What is the current status of trial NCT01953757?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2013-09. Estimated completion is 2015-03.
What interventions are being tested in trial NCT01953757?
The interventions under investigation include: Vegan diet and vitamin B12 supplement (OTHER), Vitamin B12 supplement (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01953757?
This trial is sponsored by Physicians Committee for Responsible Medicine, which has 26 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01953757's enrollment target sits among peer trials
20 1768th of 2000 higher than 140 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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