Vit D3 and Omega 3 in Chemo Induced Neuropathy
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|ClinicalTrials.gov Identifier: NCT02294149|
Recruitment Status : Unknown
Verified April 2015 by Nathaniel Bouganim, McGill University Health Centre/Research Institute of the McGill University Health Centre.
Recruitment status was: Recruiting
First Posted : November 19, 2014
Last Update Posted : April 7, 2015
|Condition or disease||Intervention/treatment||Phase|
|Cancer Neuropathy||Drug: mammalian Omega 3 Fatty acids Drug: placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized Controlled Trial of Mammalian Omega 3 With Vitamin D3 in Patients at Risk of Chemotherapy Induced Peripheral Neuropathy.|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||April 2015|
|Estimated Study Completion Date :||November 2016|
Placebo Comparator: Placebo
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.
Experimental: Omega 3 FA/Vitamin D3 sublingual
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.
Drug: mammalian Omega 3 Fatty acids
A mammalian oil derived Omega 3 FA that is a further concentrated and purified supplement as compared to the regular fish oil derived Omega 3 FA supplement.
- percentage of participants with a 50% decreases in Total neuropathy score [ Time Frame: 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02294149
|Contact: Ralph Maroun, MDfirstname.lastname@example.org|
|Contact: Nathaniel Bouganim, MD||514-934-1934 ext email@example.com|
|McGill university health center, Royal Victoria hospital||Recruiting|
|Montreal, Quebec, Canada, h3a 1a1|
|Contact: Nathaniel Bouganim, MD 514-934-1934 ext 34970 firstname.lastname@example.org|