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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apple-pectin 2000mg | Active Comparator | Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin. |
|
| Regular Non-enteric coated aspirin 325mg | Active Comparator | Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin. |
|
| Apple pectin + aspirin | Active Comparator | Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin. |
|
| Placebo Comparator | Placebo Comparator | Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apple pectin | Other | Apple pectin 2000mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Flushing | Flushing assessment performed hourly for 6 hours after niacin administration. Incidence of flushing based on if the participant experience any niacin-induced flushing during the 6 hour period after dosing. Represents # of participants that experienced event. | Hourly for 6 hours on day of dosing |
| Time to Flushing | The time it took, in minutes, for a participant to experience any flushing. Time to flush for individuals that did not experience flushing within 6 hours was set to 360 minutes. | 6 hours after dosing |
| Duration of Flushing | The amount of time, in minutes, that flushing lasted. Duration of individuals without experience flushing within 6 hours was set to 0 minutes. | 6 hours after dosing |
| Maximum Flushing Severity Score | Flushing assessment performed hourly for six hours. Assessment of severity done using the validated visual analog scale (VAS) flushing assessment tool (FAST). Severity rated using a VAS from mild (1-3), moderate (4-6), severe (7-9) to very severe (10). The maximum severity score was the maximum severity score of each individual during the 6 hours of monitoring time period. | 6 hours after dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Moriarty, MD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
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Initial screening occurred over the telephone. Subjects that met preliminary study criteria were scheduled for a screening visit. Recruitment was conducted at the University of Kansas Medical Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Apple-pectin 2000mg | Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin. |
| FG001 | Regular Non-enteric Coated Aspirin 325mg | Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin. |
| FG002 | Apple Pectin + Aspirin | Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin. |
| FG003 | Placebo Comparator | Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Apple-pectin 2000mg | Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin. |
| BG001 | Regular Non-enteric Coated Aspirin 325mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Flushing | Flushing assessment performed hourly for 6 hours after niacin administration. Incidence of flushing based on if the participant experience any niacin-induced flushing during the 6 hour period after dosing. Represents # of participants that experienced event. | This was a single-site, randomized trial, 4-arm parallel design trial. Each arm consisted of 25 randomized participants. All participants completed the study. | Posted | Number | participants | Hourly for 6 hours on day of dosing |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Apple-pectin 2000mg | Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin. |
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Limitations include: pilot design, small sample size, short duration of a one-time niacin dose, utilization of only one niacin formulation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julie-Ann Dutton, MS, RD | University of Kansas Medical Center | (913) 588-4064 | jdutton@kumc.edu |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D005483 | Flushing |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Aspirin 325 mg |
| Drug |
Aspirin 325 mg |
|
| Placebo | Other | Placebo |
|
Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
| BG002 | Apple Pectin + Aspirin | Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin. |
| BG003 | Placebo Comparator | Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m2 |
|
| Waist Circumference | Mean | Standard Deviation | inches |
|
Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin. |
| OG002 | Apple Pectin + Aspirin | Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin. |
| OG003 | Placebo Comparator | Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin. |
|
|
| Primary | Time to Flushing | The time it took, in minutes, for a participant to experience any flushing. Time to flush for individuals that did not experience flushing within 6 hours was set to 360 minutes. | All participants randomized to the study completed the study. Each arm had 25 participants. | Posted | Mean | Standard Deviation | minutes | 6 hours after dosing |
|
|
|
| Primary | Duration of Flushing | The amount of time, in minutes, that flushing lasted. Duration of individuals without experience flushing within 6 hours was set to 0 minutes. | All participants randomized to the study completed the study. Each arm had 25 participants. | Posted | Mean | Standard Deviation | minutes | 6 hours after dosing |
|
|
|
| Primary | Maximum Flushing Severity Score | Flushing assessment performed hourly for six hours. Assessment of severity done using the validated visual analog scale (VAS) flushing assessment tool (FAST). Severity rated using a VAS from mild (1-3), moderate (4-6), severe (7-9) to very severe (10). The maximum severity score was the maximum severity score of each individual during the 6 hours of monitoring time period. | All participants randomized to the study completed the study. Each arm had 25 participants. | Posted | Mean | Standard Deviation | units on a scale | 6 hours after dosing |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Regular Non-enteric Coated Aspirin 325mg | Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin. | 0 | 25 | 0 | 25 |
| EG002 | Apple Pectin + Aspirin | Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin. | 0 | 25 | 0 | 25 |
| EG003 | Placebo Comparator | Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin. | 0 | 25 | 0 | 25 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |