Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-27 @ 9:44 AM
Study NCT ID:
NCT02322203
Status:
COMPLETED
Last Update Posted:
2025-03-14
First Post:
2014-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Niacin Therapy on Lipoprotein Composition and Function
Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Organization:
Study Overview
Official Title:
Evaluation of the Effects of Niacin Therapy on Lipoprotein Composition and Function
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
\- 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 15-H-0042 | None | None | View |