NCT03674333

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 17, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

September 24, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2019

Completed
Last Updated

September 18, 2018

Status Verified

September 1, 2018

Enrollment Period

5 months

First QC Date

September 14, 2018

Last Update Submit

September 14, 2018

Conditions

Dyslipidemias

Keywords

Folic AcidDyslipidemiasHyperlipidemia

Outcome Measures

Primary Outcomes (4)

  • LDL

    mg/dL

    6 weeks

  • HDL

    mg/dL

    6 weeks

  • Triglycerides

    mg/dL

    6 weeks

  • Total Cholesterol

    mg/dL

    6 weeks

Study Arms (2)

Group A

EXPERIMENTAL

Folic acid 1mg daily will be given to the participants of Group A.

Dietary Supplement: Folic Acid

Group B

PLACEBO COMPARATOR

A Placebo (a sugar pill) will be given to the participants of the Group B.

Other: Placebo

Interventions

Folic AcidDIETARY_SUPPLEMENT

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

Group A
PlaceboOTHER

Placebo - a sugar pill

Group B

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Otherwise, healthy individuals of either sex with any of the following characteristics will be including in the study.
  • Serum cholesterol \>200mg/dl
  • Serum triglyceride \> 150mg/dl
  • Serum LDL \>100mg/dl
  • Serum HDL \< 40mg/dl

You may not qualify if:

  • Patients who have any clinically significant or unstable medical or psychiatric illnesses.
  • Patients with CKD, diabetes mellitus, coronary artery disease, with history of stroke, myocardial infarction or any chronic illnesses.
  • Substance abuse such as alcoholism excluded by taking history.
  • Patients who are pregnant are excluded by taking history and urine dipstick test where applicable.
  • Patient who are treated with any investigational drug within last 60 days.
  • Patients who are taking a statin or any other lipid lowering drug.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaheed Zulfiqar Ali Bhutto Medical University, Pakistan Institute of Medical Sciences Hospital

Islamabad, 44000, Pakistan

Location

Related Publications (3)

  • Blom HJ, Smulders Y. Overview of homocysteine and folate metabolism. With special references to cardiovascular disease and neural tube defects. J Inherit Metab Dis. 2011 Feb;34(1):75-81. doi: 10.1007/s10545-010-9177-4. Epub 2010 Sep 4.

    PMID: 20814827BACKGROUND

  • Mierzecki A, Kloda K, Bukowska H, Chelstowski K, Makarewicz-Wujec M, Kozlowska-Wojciechowska M. Association between low-dose folic acid supplementation and blood lipids concentrations in male and female subjects with atherosclerosis risk factors. Med Sci Monit. 2013 Sep 4;19:733-9. doi: 10.12659/MSM.889087.

    PMID: 24002360BACKGROUND

  • Baszczuk A, Thielemann A, Musialik K, Kopczynski J, Bielawska L, Dzumak A, Kopczynski Z, Wysocka E. The Impact of Supplementation with Folic Acid on Homocysteine Concentration and Selected Lipoprotein Parameters in Patients with Primary Hypertension. J Nutr Sci Vitaminol (Tokyo). 2017;63(2):96-103. doi: 10.3177/jnsv.63.96.

    PMID: 28552882BACKGROUND

MeSH Terms

Conditions

DyslipidemiasHyperlipidemias

Interventions

Folic Acid

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Adil Ramzan, MD

    Shaheed Zulfiqar Ali Bhutto Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Adil Ramzan, MD

CONTACT

+923336671671adilramzan@gmail.com

M Ali Arif, FRCP

CONTACT

mohammad_ali_arif@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants of both the groups will be unaware of whether they received placebo or folic acid.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Group A receives Folic Acid and Group B receives Placebo.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 14, 2018

First Posted

September 17, 2018

Study Start

September 24, 2018

Primary Completion

February 28, 2019

Study Completion

March 15, 2019

Last Updated

September 18, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will share

Individual participants data will be available. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures and appendices) will be shared to the researchers who provide a methodologically sound proposal to the primary investigator (Dr. Adil Ramzan).

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Beginning 3 months and ending 5 years following publication of the article.
Access Criteria
Proposal should be directed to "adilramzan@gmail.com". To access data, data requestors will need to sign a data access agreement. Data are available for 5 years at 3rd party website.
More information

Locations

PA(1)