Condition category
Skin and Connective Tissue Diseases
Date applied
14/11/2002
Date assigned
14/11/2002
Last edited
05/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.ccnm.edu/

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

  1. 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.

Additional files

Editorial Notes