Effect of Folic Acid Supplementation on Plasma Homocysteine Level in Obese Children

November 16, 2015 updated by: Pavinee Intakorn, Queen Sirikit National Institute of Child Health

Effect of Folic Acid Supplementation on Plasma Homocysteine Level in Obese Children: a Randomized Double Blinded Placebo Controlled Trial

The purpose of the present study was to determine whether folic acid supplementation could reduce plasma homocysteine in obese children and to determine the association between dietary folate, serum folate and homocysteine level through the randomized double blinded placebo controlled trial.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Atherosclerosis is common & remains a significant clinical problem because of leading to myocardial infarction, stroke and cardiovascular death. Many studies founded hyperhomocysteinemia is an independent risk factor for those cardiovascular diseases which take responsible for about 10% of total cardiovascular disease risk. Reduction of elevated plasma homocysteine may prevent up to 25% of cardiovascular events. One of modifiable cause of hyperhomocysteinemia is prevention of vitamin deficiency, especially folate deficiency.

Obese Thai children are probable risk for folate deficiency due to low dietary folate intake and low serum folate level from unbalanced diet (low vegetables intake & high fat diet) and high prevalence of thalassemia. Moreover obese children are also at risk of atherosclerosis. However, no data have been reported about effect of folic acid supplementation on homocysteine level in these patients.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10400
        • Queen Sirikit National Institute of Child Health
      • Bangkok, Thailand, 10400
        • Department of Pediatrics, Queen Sirikit National Institute of Child Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 16 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient age between 9-18 years
  • Diagnosed obesity (BMI more than median plus two of standard deviation for age and sex according to WHO reference 2007)

Exclusion Criteria:

  • Secondary obesity
  • Thalassemia disease
  • Renal and hepatic dysfunction
  • Drugs: anticonvulsant, estrogen, thiazides, metformin, cholestyramine, methotrexate, fibrates, nicotinic acid
  • Previous vitamin supplementation 1 month before study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
placebo tablet in the same appearance and taste with folic acid orally once a day for 8 weeks of the study
Drug: placebo
sugar tablet manufactured to mimic folic acid tablet
Experimental: folic acid
Folic acid tablet 5mg per day orally (5mg/tablet) once a day for 8 weeks of the study
Drug: Folic Acid
yellow tablet contained 5mg of folic acid, manufactured from the Government Pharmaceutical Organization, Ministry of Public Health, Thailand

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of Homocysteine Level
Time Frame: 8 weeks
Mean difference of changes of homocysteine level between 2 treatment groups
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Folate Level
Time Frame: 8 weeks
correlation between serum folate and plasma homocysteine level
8 weeks
Serum Vitamin B12 Level
Time Frame: 8 weeks
correlation between serum vitamin B12 and plasma homocysteine level
8 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of Hyperhomocysteinemia
Time Frame: 8 weeks
prevalence of hyperhomocysteinemia in Thai obese children
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Sirikit National Institute of Child Health

Collaborators

Chulalongkorn University

Investigators

  • Principal Investigator: Orawan Iamopas, MD., Queen Sirikit National Institute of Child Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

January 7, 2013

First Submitted That Met QC Criteria

January 9, 2013

First Posted (Estimate)

January 11, 2013

Study Record Updates

Last Update Posted (Estimate)

December 11, 2015

Last Update Submitted That Met QC Criteria

November 16, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Folic-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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