Trial Outcomes & Findings for Effects of Niacin Therapy on Lipoprotein Composition and Function (NCT NCT02322203)
NCT ID: NCT02322203
Last Updated: 2025-03-14
Results Overview
Measure the mean percentage of niacin monotherapy on high-density lipoprotein (HDL) protein concentration
COMPLETED
NA
22 participants
20 weeks
2025-03-14
Participant Flow
Participant milestones
| Measure |
Niacin ER in Healthy Participants and Its Effects on Lipoprotein Composition and Function
Niacin extended release (ER) to be given as follows: 500 mg/day for 1 week, then 1000 mg/day for 1 week, then 2000 mg/day for 14 weeks in healthy participants.
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|---|---|
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Overall Study
STARTED
|
22
|
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Overall Study
COMPLETED
|
14
|
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Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Niacin Therapy on Lipoprotein Composition and Function
Baseline characteristics by cohort
| Measure |
Niacin ER in Healthy Participants and Its Effects on Lipoprotein Composition and Function
n=22 Participants
Niacin extended release (ER) to be given as follows: 500 mg/day for 1 week, then 1000 mg/day for 1 week, then 2000 mg/day for 14 weeks in healthy participants.
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|---|---|
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Age, Continuous
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38.5 years
STANDARD_DEVIATION 13.6 • n=99 Participants
|
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Sex: Female, Male
Female
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14 Participants
n=99 Participants
|
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Sex: Female, Male
Male
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8 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
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Region of Enrollment
United States
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22 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 20 weeksPopulation: Out of the 14 participants that completed study, 3 participants were considered to be non-responders and not included in data analysis. Therefore, 11 participants were included in data analysis.
Measure the mean percentage of niacin monotherapy on high-density lipoprotein (HDL) protein concentration
Outcome measures
| Measure |
Niacin ER in Healthy Participants and Its Effects on Lipoprotein Composition and Function
n=11 Participants
Niacin extended release (ER) to be given as follows: 500 mg/day for 1 week, then 1000 mg/day for 1 week, then 2000 mg/day for 14 weeks in healthy participants.
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|---|---|
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Mean Percent Change in High-density Lipoprotein Protein Concentration
High-density lipoprotein cholesterol
|
16.0 Percentage Change
Standard Deviation 11.1
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Mean Percent Change in High-density Lipoprotein Protein Concentration
Low-density lipoprotein cholesterol
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-20.0 Percentage Change
Standard Deviation 24.7
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Mean Percent Change in High-density Lipoprotein Protein Concentration
Triglyceride
|
-15.0 Percentage Change
Standard Deviation 21.2
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Mean Percent Change in High-density Lipoprotein Protein Concentration
Total Cholesterol
|
-11.0 Percentage Change
Standard Deviation 13.2
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PRIMARY outcome
Timeframe: 20 weeksPopulation: Out of the 14 participants that completed study, 3 participants were considered to be non-responders and not included in data analysis. Therefore, 11 participants were included in data analysis.
Measure the effect proteins with changes in protein composition of niacin monotherapy on high-density lipoprotein (HDL) protein composition. High-density lipoprotein protein were measured using Nuclear magnetic resonance (NMR) spectroscopy. NMR spectroscopy is a technique that uses the magnetic properties of atomic nuclei to analyze the chemical and physical properties of molecules or atoms. NMR spectroscopy is non-destructive and non-invasive, and can be used to study the structure, dynamics, and chemical reactions of molecules. NMR procedures numerical results which are comparable to laboratory results, and these data were used to measure the outcomes reported.
Outcome measures
| Measure |
Niacin ER in Healthy Participants and Its Effects on Lipoprotein Composition and Function
n=5 Proteins
Niacin extended release (ER) to be given as follows: 500 mg/day for 1 week, then 1000 mg/day for 1 week, then 2000 mg/day for 14 weeks in healthy participants.
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|---|---|
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Change in Proteins of High-density Lipoprotein Protein Composition on Niacin Monotherapy
|
5 proteins
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Adverse Events
Niacin ER in Healthy Participants and Its Effects on Lipoprotein Composition and Function
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Niacin ER in Healthy Participants and Its Effects on Lipoprotein Composition and Function
n=22 participants at risk
Niacin extended release (ER) to be given as follows: 500 mg/day for 1 week, then 1000 mg/day for 1 week, then 2000 mg/day for 14 weeks in healthy participants.
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|---|---|
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Cardiac disorders
Palpitations
|
4.5%
1/22 • 20 weeks
Adverse events were pre-specified to be collected as a single Arm/Group irrespective of dose level.
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Gastrointestinal disorders
Diarrhea
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4.5%
1/22 • 20 weeks
Adverse events were pre-specified to be collected as a single Arm/Group irrespective of dose level.
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|
Investigations
CPK increased
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4.5%
1/22 • 20 weeks
Adverse events were pre-specified to be collected as a single Arm/Group irrespective of dose level.
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|
Investigations
Low Thyroid Function
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4.5%
1/22 • 20 weeks
Adverse events were pre-specified to be collected as a single Arm/Group irrespective of dose level.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.5%
1/22 • 20 weeks
Adverse events were pre-specified to be collected as a single Arm/Group irrespective of dose level.
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Additional Information
Marcelo J. Amar, M.D. Principal Investigator, NIH, NHLBI
National Heart Lung and Blood Institute (NHLBI)
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place