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

Phase 4

Completed

• Conditions: Hyperhomocysteinemia; Obesity
• Interventions: Drug: placebo; Drug: Folic Acid

• Registration Number: NCT01766310
• Lead Sponsor: Queen Sirikit National Institute of Child Health

Brief Summary

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

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 Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-01-07
• Study First Submitted QC: 2013-01-09
• Study First Posted: 2013-01-11
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Results First Submitted: 2014-08-10
• Results First Submitted QC: 2015-10-19
• Status Verified: 2015-11
• Results First Posted: 2015-11-16
• Last Update Submitted: 2015-11-16
• Last Update Posted: 2015-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	placebo tablet in the same appearance and taste with folic acid orally once a day for 8 weeks of the study
folic acid	Folic Acid	Folic acid tablet 5mg per day orally (5mg/tablet) once a day for 8 weeks of the study

Primary Outcome Measures

Name	Time	Method
Changes of Homocysteine Level	8 weeks	Mean difference of changes of homocysteine level between 2 treatment groups

Secondary Outcome Measures

Name	Time	Method
Serum Vitamin B12 Level	8 weeks	correlation between serum vitamin B12 and plasma homocysteine level
Serum Folate Level	8 weeks	correlation between serum folate and plasma homocysteine level

Trial Locations

Locations (2)

Department of Pediatrics, Queen Sirikit National Institute of Child Health; 🇹🇭 Bangkok, Thailand

Queen Sirikit National Institute of Child Health; 🇹🇭 Bangkok, Thailand