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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Hyperhomocysteinemia, Obesity

Intervention / Treatment
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* Drug: Folic Acid
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of Homocysteine Level | 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 | correlation between serum folate and plasma homocysteine level | 8 weeks | 
| Serum Vitamin B12 Level | correlation between serum vitamin B12 and plasma homocysteine level | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Children, Folic acid, Folate, Homocysteine, Obese