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 |
| Protocol serial number | N/A |
| Sponsor | Canadian College of Naturopathic Medicine (Canada) |
| Funders | Canadian College of Naturopathic Medicine (Canada), 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. |
- 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
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 |
|---|---|
| emills@ccnm.edu |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Niacin (nicotinic acid) |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 68 |
| Key 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 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2002 |
| Date of final enrolment | 31/12/2002 |
Locations
Countries of recruitment
- Canada
Study participating centre
Director of Research
North York, Ontario
M2K 1E2
Canada
M2K 1E2
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
