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Effect of Adding Folic Acid on Lipid Parameters in Population With Dyslipidemias

NCT03674333 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2018-09-18

No results posted yet for this study

Summary

Background: Homocysteinemia is associated with increased risk of stroke, dyslipidemias, dementia, peripheral vascular disease and coronary artery disease. folic acid is involved in the metabolism of homocysteine. Folic acid supplementation helps to reduce homocysteine levels and lowering of homocysteine may cause improvement in serum lipid profile. In this study we will assess the effect of folic acid supplementation for 6 weeks, on lipid parameter in patients who have dyslipidemia.

Methods: It is a placebo controlled randomized trial, consisting of two groups, Group A (n=34) and Group B (n=34). Group A (intervention group) will be given Folic acid supplements and the second group will be given a placebo. After 6 weeks changes in lipid parameters, will be measured in both groups.

Discussion: Folic acid is water soluble vitamin also known as vitamin B-9. Folic acid works as co-factor in many biochemical enzymatic reactions. Homocysteine metabolism also requires folic acid, homocysteinemia may worsen renal function, lipid parameter, accelerate atherosclerosis, angiopathies, and progression of dementia, also increase the risk of stroke and coronary artery disease. In this study, Group A (treatment Group) will be given folic acid supplementation while the Group B (Placebo Group) will be given placebo and at the end of 6 weeks, HDL, LDL, Triglycerides and serum cholesterol levels will be measured and compared with the pre-treatment levels. If Post-treatment group shows significant decrease in serum LDL, total cholesterol, triglycerides and increase in HDL then Folic acid supplementation may be routinely recommended for patient with dyslipidemias.

Conditions

  • Dyslipidemias

Interventions

DIETARY_SUPPLEMENT

Folic Acid

Folic acid is a water soluble vitamin, required for various biological functions in human body, including metabolism of homocysteine.

OTHER

Placebo

Placebo - a sugar pill

Sponsors & Collaborators

  • Shaheed Zulfiqar Ali Bhutto Medical University

    lead OTHER

Principal Investigators

  • Adil Ramzan, MD · Shaheed Zulfiqar Ali Bhutto Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-24
Primary Completion
2019-02-28
Completion
2019-03-15

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03674333 on ClinicalTrials.gov