Contact information
Type
Scientific
Primary contact
Mr Edward Mills
ORCID ID
Contact details
Director of Research
Canadian College of Naturopathic Medicine
1255 Sheppard Ave East
North York
Ontario
M2K 1E2
Canada
+1 416 498 1255 ext 324
emills@ccnm.edu
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Cutaneous reactions (flushing)
Intervention
Participants divided into two groups:
1. Verum group takes one 500 mg tablet of niacin
2. The control group takes a placebo
Intervention type
Drug
Phase
Not Specified
Drug names
Niacin (nicotinic acid)
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2002
Overall trial end date
31/12/2002
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age range 20 - 60 years
2. Currently enrolled at The Canadian College of Naturopathic Medicine (CCNM)
3. Not currently taking any prescribed medication that influences gastric acid secretion
4. Does not have current or past liver disease (e.g., chronic active hepatitis, cirrhosis, etc)
5. Does not have current or past history of gout or active gout
6. Does not have current or past gastrointestinal disease (e.g., peptic ulcer disease, gastric cancer, etc)
7. Does not have current or past diagnosis of diabetes mellitus
8. Does not have a past episode or history of intolerance to niacin
9. Was able to complete the intake form
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
68
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/2002
Recruitment end date
31/12/2002
Locations
Countries of recruitment
Canada
Trial participating centre
Director of Research
North York, Ontario
M2K 1E2
Canada
Sponsor information
Organisation
Canadian College of Naturopathic Medicine (Canada)
Sponsor details
1255 Sheppard Ave East
North York
Ontario
M2K 1E2
Canada
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Canadian College of Naturopathic Medicine (Canada)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Jamieson Laboratories donated the study drug and placebo. They had no role in study design, data analysis, and they have not received the study results.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=14614780
Publication citations
-
Results
Mills E, Prousky J, Raskin G, Gagnier J, Rachlis B, Montori VM, Juurlink D, The safety of over-the-counter niacin. A randomized placebo-controlled trial [ISRCTN18054903]., BMC Clin Pharmacol, 2003, 3, 4, doi: 10.1186/1472-6904-3-4.