We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Niacin Therapy on Lipoprotein Composition and Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02322203
Recruitment Status : Completed
First Posted : December 23, 2014
Last Update Posted : April 15, 2021
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

Tracking Information
First Submitted Date  ICMJE December 20, 2014
First Posted Date  ICMJE December 23, 2014
Last Update Posted Date April 15, 2021
Actual Study Start Date  ICMJE March 25, 2015
Actual Primary Completion Date April 7, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2018)
Changes in protein or lipid composition of any lipoprotein fraction and changes in vascular compliance as measured by CAVI [ Time Frame: Ongoing ]
The primary outcome measurements of this study are changes in protein or lipid composition of any lipoprotein fraction and changes invascular compliance as measured by CAVI.
Original Primary Outcome Measures  ICMJE
 (submitted: December 20, 2014)
Changes in protein or lipid composition of any lipoprotein fraction and changes in vascular compliance as measured by CAVI [ Time Frame: Ongoing ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Niacin Therapy on Lipoprotein Composition and Function
Official Title  ICMJE Evaluation of the Effects of Niacin Therapy on Lipoprotein Composition and Function
Brief Summary

Background:

- Niacin is a vitamin in many foods, including meats, fish, fruits, and vegetables. It is often used as a dietary supplement that causes many improvements in the body. Researchers think it can affect heart health.

Objective:

- To better understand the good effects of niacin supplementation on cholesterol, fat metabolism, and vascular health.

Eligibility:

- Adults 18 years of age and older with fasting good cholesterol (HDL-C) below 60 mg/dL.

Design:

  • Participants will come to the clinic 4 times during the study.
  • They will complete a 7-day food journal before visits 1 and 3.
  • At visit 1, participants will be screened with questions about their diet and exercise, medical history, and any drugs and vitamins they take. Vital signs and body mass index will be measured.
  • They will have a Cardio-Ankle Vascular Index (CAVI) test of the arteries. Blood pressure will be taken in the arms and legs and the heart will be monitored.
  • Blood will be drawn. Participants will fast for 8 12 hours before this.
  • Women will have a pregnancy test.
  • Eligible participants will get a 2-week supply of niacin. They will take 2 tablets daily for one week, then 4 daily.
  • Visit 2 will be 2 weeks after visit 1 and the niacin dose will be increased. Visit 3 will be 16 weeks after visit 1, and participants will stop taking niacin. Visit 4 will be 4 6 weeks after stopping niacin.
  • During study visits, participants will repeat visit 1 tests.
Detailed Description This single center clinical pilot study will investigate the effects of niacin on blood lipids and lipoprotein composition in human subjects who are healthy. Niacin (vitamin B3 or nicotinic acid) is a common nutrient found in many foods and is currently sold over the counter as a nutritional supplement. Extended-release versions of niacin are available over the counter (e.g., Slo-Niacin) or by prescription (Niaspan) and help to alleviate symptoms of flushing associated with larger doses of the vitamin. Studies of the effects of niacin therapy on clinical lipid measures consistently indicate a shift toward a healthier lipoprotein profile with increased HDL-C and decreases in both triglyceride and LDL-C. Despite this favorable shift in lipid profile, cardiovascular outcome studies on patients receiving niacin alone or in combination with statin therapy have resulted in mixed results creating uncertainty of the value of niacin therapy. The proposed study will examine in detail the effects of niacin therapy on lipoprotein composition and function, while also tracking measures of vascular health.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
This novel pilot study will be carried out at the NIH Clinical Center outpatient clinic 7 in healthy volunteers. We will screen up to 200 subjects, males and females, to obtain at least 32 completed studies. Participants will be recruited via flyer, and/or recruitment advertisement placed in the NIH Record, the NHLBI Recruitment website, the Clinical Center News and by email/listserv.
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Cardiovascular Disease
Intervention  ICMJE Dietary Supplement: Niacin Extended Release
Subjects will receive a 2 week supply of the dietary supplement Rugby Extended Release Niacin (250 mg/tablet) Niacin and will be instructed to take 2 tablets per day (500 mg/day) for the first seven days and then increase to 4 tablets per day (1000 mg/day) during the following 7 days. Subjects will then be escalated to 2000 mg/day for 14 weeks.
Other Name: Niacin Extended Release (ER); Niacin
Study Arms  ICMJE Experimental: 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.
Intervention: Dietary Supplement: Niacin Extended Release
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 24, 2019)
24
Original Estimated Enrollment  ICMJE
 (submitted: December 20, 2014)
200
Actual Study Completion Date  ICMJE July 23, 2019
Actual Primary Completion Date April 7, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • INCLUSION CRITERIA:
  • Males and females who are at least 18 years of age at time of enrollment.
  • Subject understands the investigational nature of the study and provides written, informed consent.

EXCLUSION CRITERIA:

  • Subjects taking any lipid modification therapy, including but not limited to statins, fibrates and bile acid sequestrants.
  • Subjects taking fish oil or any other supplements, which in the investigator s opinion may interfere with the study.
  • Subjects with acute liver disease or active peptic ulcer disease.
  • Subjects with elevated uric acid levels greater than 10 mg/dL or gout
  • Pregnancy or women currently breastfeeding.
  • Female subjects taking hormonal contraceptives or hormone replacement therapy may be included in this study only if they have been on a stable dose for at least 3 months.
  • BMI less than 18.5
  • Subjects with weight that varies greater than 20% over the past 3 months.
  • Subjects taking the following medications for at least six weeks, which may interfere with the study, will be excluded: BAS, antibiotics, anticoagulants, anticonvulsants, antiarrhythmic, Cyclosporine, Mycophenolate and Synthroid. Subjects with chronic diarrhea, gastric bypass or lap band procedures, ostomies, bowel motility problems, or other conditions that could affect intestinal fat absorption.
  • Subjects initiating new medications or patients on multiple medications may also be excluded.
  • Inability to swallow capsules
  • Patients with a history of type I or type II diabetes or HbA1c greater than 6.5%.
  • Volunteers may also be excluded, if in the opinion of the study investigators, they have some other condition or disorder that may adversely affect the outcome of the study or the safety of the volunteer.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02322203
Other Study ID Numbers  ICMJE 150042
15-H-0042
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
Original Responsible Party Same as current
Current Study Sponsor  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marcelo J Amar, M.D. National Heart, Lung, and Blood Institute (NHLBI)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP