NCT01766310

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Queen Sirikit National Institute of Child Health · Other Government
• Sex: All
• Age: 9 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hyperhomocysteinemia
• Obesity

Interventions

Type	Name	Description
DRUG	Folic Acid	yellow tablet contained 5mg of folic acid, manufactured from the Government Pharmaceutical Organization, Ministry of Public Health, Thailand
DRUG	placebo	sugar tablet manufactured to mimic folic acid tablet

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2013-01-11
• Last updated: 2015-12-11
• Results posted: 2015-11-16

Locations

2 sites across 1 country: Thailand