Time variability of flush-onset and flush tolerabililty in individuals given 500 mg niacin (nicotinic acid): a randomised controlled trial

ISRCTN ISRCTN18054903
DOI https://doi.org/10.1186/ISRCTN18054903
Secondary identifying numbers N/A
Submission date
14/11/2002
Registration date
14/11/2002
Last edited
05/09/2007
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Edward Mills
Scientific

Director of Research
Canadian College of Naturopathic Medicine
1255 Sheppard Ave East
North York, Ontario
M2K 1E2
Canada

Phone +1 416 498 1255 ext 324
Email emills@ccnm.edu

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedCutaneous reactions (flushing)
InterventionParticipants divided into two groups:
1. Verum group takes one 500 mg tablet of niacin
2. The control group takes a placebo
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Niacin (nicotinic acid)
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/2002
Completion date31/12/2002

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants68
Key inclusion criteria1. 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
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/01/2002
Date of final enrolment31/12/2002

Locations

Countries of recruitment

  • Canada

Study participating centre

Director of Research
North York, Ontario
M2K 1E2
Canada

Sponsor information

Canadian College of Naturopathic Medicine (Canada)
University/education

1255 Sheppard Ave East
North York, Ontario
M2K 1E2
Canada

Website http://www.ccnm.edu/
ROR logo "ROR" https://ror.org/03pjwtr87

Funders

Funder type

University/education

Canadian College of Naturopathic Medicine (Canada)

No information available

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.

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 13/11/2003 Yes No