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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 is a NA study that has completed, run by Physicians Committee for Responsible Medicine. The registered enrollment target is 20 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01953757
The ClinicalTrials.gov registry entry for NCT01953757 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Physicians Committee for Responsible Medicine, which has 26 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Vegan diet and vitamin B12 supplement is the first listed.
NCT01953757 reports 0 study locations.
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.
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