DyslipidemiasNCT03674333
Effect of Adding Folic Acid on Lipid Parameters in Population With Dyslipidemias
A study testing Folic Acid in people with Dyslipidemias, run by Shaheed Zulfiqar Ali Bhutto Medical University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemias
- What is being tested?
- Folic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 sitePakistan
- Study dates
- 24 Sep 2018to 15 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
M Ali Arif, FRCP contact
Pakistan1 site
Shaheed Zulfiqar Ali Bhutto Medical University, Pakistan Institute of Medical Sciences Hospital
Islamabad, 44000
Fibhaa Syed, FCPS, MRCP, 923335300002, Fibhaasyed@gmail.com
About this study
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.
Read the detailed description
Hyperlipidemia, increases the risk of stroke, hypertension, coronary artery disease and other associated disorders. World-wide about one-third of coronary artery disease is attributed high cholesterol. Overall it has been estimated that elevated blood cholesterol causes 26 million deaths (4.5% of the total deaths) world-wide. Hyperlipidemias is a major cause of morbidity in both developed and developing countries as a risk factor for stroke and coronary artery disease. The prevalence of raised total cholesterol increased noticeably according to the income level of the country. In low income countries around a quarter of adults had raised total cholesterol, in lower middle income countries this rose to around a third of the population for both sexes. In high-income countries, over 50% of adults had raised total cholesterol; more than double the level of the low-income countries.
Homocysteine, on the other hand, is a sulfur amino acid, which is metabolized by two pathways, either it is re-methylated to methionine or it undergoes trans-sulfuration to cystathionine which is eventually converted into cysteine, an amino acid. Folic acid is involved in remethylation of homocysteine to methionine. Thus, folic acid supplementation may enhance the metabolism of homocysteine level and thereby may decrease its level in blood. Homocysteine in blood is termed as homocysteinemia. Homocysteinemia is associated with dyslipidemias, increased risk of atherosclerosis, micro-angiopathies, coronary artery disease, stroke, dementia and also found to be associated with suppressed immunity. Supplementation with folic acid may lower homocysteine level by accelerating its metabolism to methionine. In this study investigators will be assessing the effect of folate supplementation on the lipid profile, particularly on the blood levels of HDL, LDL, Triglycerides and total cholesterol. The HDL has cardio-protective effect, while on the other hand, the higher level of LDL, total cholesterol and triglycerides may accelerate atherosclerosis, angiopathies and increases the risk of stroke and heart diseases.
Research question: Does addition of folic acid supplementation decrease LDL, total cholesterol, triglycerides and increase HDL in patients with dyslipidemias.
OBJECTIVE:
To assess the effect of folic acid supplementation on HDL, LDL, total cholesterol and triglycerides in patients with dyslipidemias.
HYPOTHESIS Addition of folic acid supplementation will improve lipid parameters (HDL, total cholesterol, triglycerides \& LDL) in patients with dyslipidemias.
- Conditions
- Dyslipidemias
- Being tested
- Folic Acid, Placebo
- Keywords
- Folic Acid, Dyslipidemias, Hyperlipidemia
- Medical subject headings
- Dyslipidemias, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Folic AcidDietary supplement
Folic acid is a water soluble vitamin, required for various biological functions in human body, including metabolism of homocysteine.
PlaceboOther
Placebo - a sugar pill
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Folic acid 1mg daily will be given to the participants of Group A. Receives: Dietary Supplement: Folic Acid |
| Group B | Placebo comparator | A Placebo (a sugar pill) will be given to the participants of the Group B. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL
mg/dL
Measured: 6 weeks
HDL
mg/dL
Measured: 6 weeks
Triglycerides
mg/dL
Measured: 6 weeks
Total Cholesterol
mg/dL
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start24 Sep 2018 (estimated)
- Primary completion28 Feb 2019 (estimated)
- Study completion15 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group A receives Folic Acid and Group B receives Placebo.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaheed Zulfiqar Ali Bhutto Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adil Ramzan, Shaheed Zulfiqar Ali Bhutto Medical University
- Investigators
- Adil Ramzan, MD, Principal investigator, Shaheed Zulfiqar Ali Bhutto Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03674333
- Sponsor's protocol ID
- U1111-1220-5275
- Status last verified
- Sep 2018
- First submitted
- 14 Sep 2018
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Publications
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.
PubMed 20814827Mierzecki 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.
PubMed 24002360Baszczuk 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.
PubMed 28552882
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adding Folic Acid on Lipid Parameters in Population With Dyslipidemias
- ClinicalTrials.gov ID
- NCT03674333
- Acronym / sponsor ID
- U1111-1220-5275
- Conditions
- Dyslipidemias
- Keywords
- Folic Acid, Dyslipidemias, Hyperlipidemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Shaheed Zulfiqar Ali Bhutto Medical UniversityUniversity, hospital or other
- Study start
- 24 Sep 2018 (estimated)
- Primary completion
- 28 Feb 2019 (estimated)
- Study completion
- 15 Mar 2019 (estimated)
- First posted
- 17 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Hyperlipidemia, increases the risk of stroke, hypertension, coronary artery disease and other associated disorders. World-wide about one-third of coronary artery disease is attributed high cholesterol. Overall it has been estimated that elevated blood cholesterol causes 26 million deaths (4.5% of the total deaths) world-wide. Hyperlipidemias is a major cause of morbidity in both developed and developing countries as a risk factor for stroke and coronary artery disease. The prevalence of raised total cholesterol increased noticeably according to the income level of the country. In low income countries around a quarter of adults had raised total cholesterol, in lower middle income countries this rose to around a third of the population for both sexes. In high-income countries, over 50% of adults had raised total cholesterol; more than double the level of the low-income countries.
Homocysteine, on the other hand, is a sulfur amino acid, which is metabolized by two pathways, either it is re-methylated to methionine or it undergoes trans-sulfuration to cystathionine which is eventually converted into cysteine, an amino acid. Folic acid is involved in remethylation of homocysteine to methionine. Thus, folic acid supplementation may enhance the metabolism of homocysteine level and thereby may decrease its level in blood. Homocysteine in blood is termed as homocysteinemia. Homocysteinemia is associated with dyslipidemias, increased risk of atherosclerosis, micro-angiopathies, coronary artery disease, stroke, dementia and also found to be associated with suppressed immunity. Supplementation with folic acid may lower homocysteine level by accelerating its metabolism to methionine. In this study investigators will be assessing the effect of folate supplementation on the lipid profile, particularly on the blood levels of HDL, LDL, Triglycerides and total cholesterol. The HDL has cardio-protective effect, while on the other hand, the higher level of LDL, total cholesterol and triglycerides may accelerate atherosclerosis, angiopathies and increases the risk of stroke and heart diseases.
Research question: Does addition of folic acid supplementation decrease LDL, total cholesterol, triglycerides and increase HDL in patients with dyslipidemias.
OBJECTIVE:
To assess the effect of folic acid supplementation on HDL, LDL, total cholesterol and triglycerides in patients with dyslipidemias.
HYPOTHESIS Addition of folic acid supplementation will improve lipid parameters (HDL, total cholesterol, triglycerides \& LDL) in patients with dyslipidemias.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Group A receives Folic Acid and Group B receives Placebo.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Dietary Supplement: Folic AcidFolic acid 1mg daily will be given to the participants of Group A. |
| Group B | Placebo comparator | Other: PlaceboA Placebo (a sugar pill) will be given to the participants of the Group B. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1. Otherwise, healthy individuals of either sex with any of the following characteristics will be including in the study.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Folic AcidFolic acid is a water soluble vitamin, required for various biological functions in human body, including metabolism of homocysteine. | Dietary supplement | Group A |
| PlaceboPlacebo - a sugar pill | Other | Group B |
Primary outcome
LDL
Time frame: 6 weeks
mg/dL
HDL
Time frame: 6 weeks
mg/dL
Triglycerides
Time frame: 6 weeks
mg/dL
Total Cholesterol
Time frame: 6 weeks
mg/dL
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2018.
- Background: PubMed 20814827Blom 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.
- Background: PubMed 24002360Mierzecki 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.
- Background: PubMed 28552882Baszczuk 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.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M Ali Arif, FRCP contact
Adil Ramzan, MD principal investigator
Shaheed Zulfiqar Ali Bhutto Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Folic Acid in people with Dyslipidemias, run by Shaheed Zulfiqar Ali Bhutto Medical University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adil Ramzan, MD (+923336671671, adilramzan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LDL (time frame: 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03674333, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2018.