Alternative Options to Minimize Niacin-Induced Flushing
This study has been completed.
Sponsor:
University of Kansas
Information provided by:
University of Kansas
ClinicalTrials.gov Identifier:
NCT00895193
First received: May 6, 2009
Last updated: January 11, 2011
Last verified: January 2011
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Purpose
Niacin (Vitamin B3) is known to effectively and safely treat hypercholesterolemia. However, use of niacin is limited due to incidents of flushing which limits its acceptability. Some information suggests that applesauce can reduce the incidence and severity of flushing. The apple pectin in particular is thought to be the ingredient that affects this reaction. To determine if the apple pectin does affect flushing from niacin, the investigators will study the affects of isolated apple pectin in pill form. The investigators plan on recruiting 100 patients, and giving them 1000 mg of Niacin to induce flushing. Patients will be divided into 4 treatment groups and receive either pectin, aspirin, a combination of both, or placebo. Incidents and severity of flushing will be monitored for up to 6 hours post Niacin ingestion.
| Condition | Intervention |
|---|---|
|
Hypercholesterolemia Flushing |
Other: Apple pectin Drug: Aspirin 325 mg Other: Apple pectin 2000 mg + aspirin 325 mg Other: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Supportive Care |
| Official Title: | Alternative Options to Minimize Niacin-Induced Flushing |
Resource links provided by NLM:
Further study details as provided by University of Kansas:
Primary Outcome Measures:
- Presence or absence of flushing, Flushing assessment tool [ Time Frame: Hourly for 6 hours on day of dosing ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2009 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Apple pectin 2000mg
|
Other: Apple pectin
Apple pectin 2000mg
|
|
Active Comparator: 2
Aspirin 325 mg
|
Drug: Aspirin 325 mg
Aspirin 325 mg
|
|
Active Comparator: 3
Apple pectin 2000mg and aspirin 325 mg
|
Other: Apple pectin 2000 mg + aspirin 325 mg
Apple pectin 2000mg + aspirin 32 mg
|
|
Placebo Comparator: 4
Placebo
|
Other: Placebo
Placebo
|
Eligibility| Ages Eligible for Study: | 21 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- An adult between 21 and 70 years of age.
- Male or female (If female must be postmenopausal for at least 1 year, surgically sterile or using an effective form of contraception).
- Able to speak and read English.
- Willing to comply with study specific instructions, and complete all study procedures according to protocol.
- Able to understand study rationale and sign informed consent.
Exclusion Criteria:
- Females of child-bearing potential not using acceptable method of contraception and perimenopausal females.
- History of gout
- History of diabetes mellitus
- History of coronary heart disease
- History of, or currently experiencing, renal disease including, but not limited to, renal insufficiency, nephrolithiasis or chronic renal failure.
- History of, or currently experiencing, major chronic gastrointestinal condition including gallbladder disease, liver disease and peptic ulcer disease
- Known sensitivity to niacin, Aspirin or nonsteroidal anti-inflammatory agents (NSAIDs)
- History of migraine or cluster headaches
- Currently using antihistamines, aspirin or NSAIDS on a consistent basis
- Presence or history of any medical or psychosocial condition that, in the opinion of the investigator, would limit the patient's successful participation or would compromise the patient's safe participation.
- Lab abnormalities at screening, including but not limited to elevated liver enzymes or blood sugar levels that might indicate additional risk to the patient's continued participation.
- Currently taking medication that might be contraindicated with the study drug or Niacin or study procedures (including Niacin, lipid-lowering drugs, chronic aspirin or laxative use).
- Clinically significant finding from physical exam that would affect the patient's safe participation or completion of the study.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00895193
Locations
| United States, Kansas | |
| University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160 | |
Sponsors and Collaborators
University of Kansas
Investigators
| Principal Investigator: | Patrick Moriarty, MD | University of Kansas |
More Information
No publications provided
| Responsible Party: | Patrick Moriarty MD, University of Kansas Medical Center |
| ClinicalTrials.gov Identifier: | NCT00895193 History of Changes |
| Other Study ID Numbers: | 11627 |
| Study First Received: | May 6, 2009 |
| Last Updated: | January 11, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Kansas:
|
Niacin Hypercholesterolemia Flushing |
Additional relevant MeSH terms:
|
Flushing Hypercholesterolemia Signs and Symptoms Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Aspirin Niacin Pectin Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Hematologic Agents Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013