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

Queen Sirikit National Institute of Child Health

Status and phase: Completed; Phase 4

Conditions: Hyperhomocysteinemia; Obesity

Treatments: Drug: placebo; Drug: Folic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT01766310

Folic-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 9 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

placebo tablet in the same appearance and taste with folic acid orally once a day for 8 weeks of the study

Treatment:

Drug: placebo

folic acid

Experimental group

Description:

Folic acid tablet 5mg per day orally (5mg/tablet) once a day for 8 weeks of the study

Treatment:

Drug: Folic Acid