Clinical trial · Interventional
Vit D3 and Omega 3 in Chemo Induced Neuropathy
A Randomized Controlled Trial of Mammalian Omega 3 With Vitamin D3 in Patients at Risk of Chemotherapy Induced Peripheral Neuropathy.
NCT02294149CI-TRIAL-00017414unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine whether administration of mammalian Omega 3 FA(fatty acid) with Vitamin D3 supplements would lower or prevent the risk of neuropathy due to chemotherapy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Neuropathy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| mammalian Omega 3 Fatty acids | Drug | — | UNRESOLVED |
| placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- A ineffective placebo drug with the same taste, route of administration and physical appearance as the study drug (omega 3/Vit D 3) that has received approval by health Canada.
- interventionNames
- Drug: placebo
- type
- EXPERIMENTAL
- label
- Omega 3 FA/Vitamin D3 sublingual
- description
- patients will be allocated randomly to receive Sub-lingual Omega 3 FA and Vitamin D3 supplements for 6 months, twice daily ,1/2 tea spoon with instructions to keep it under the tongue for 45 sec.
- interventionNames
- Drug: mammalian Omega 3 Fatty acids
Primary outcomes (1)
- measure
- percentage of participants with a 50% decreases in Total neuropathy score
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Will be receiving chemotherapy(Platinums and/or Taxanes) in the following 2 weeks. * Histologically confirmed diagnosis of cancer * ECOG 0 to 2 Exclusion Criteria: * Prior chemotherapy treatment * Pre-existing peripheral PN due to DM,HIV, alcohol abuse, thyroid dysfunction and hereditary PN associated disorders. * Taking any nutritional supplement( fish oil, vitamins and minerals) at least there months before enrollment.
References
Publications (0)
Data not yet available
No reference posted for this study.