Skip to main content
OpenTrials
Completed

NCT Number: NCT01766310

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hyperhomocysteinemia Amino Acid Metabolism, Inborn Errors Avitaminosis Body Weight Congenital, Hereditary, and Neonatal Diseases and Abnormalities Deficiency Diseases Genetic Diseases, Inborn Malabsorption Syndromes Malnutrition Metabolic Diseases Metabolism, Inborn Errors Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Vitamin B Deficiency

Age range

9 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Folic Acid

Drug

yellow tablet contained 5mg of folic acid, manufactured from the Government Pharmaceutical Organization, Ministry of Public Health, Thailand

Placebo

Drug

sugar tablet manufactured to mimic folic acid tablet

Primary outcomes

  1. Changes of Homocysteine Level

    Time frame: 8 weeks

    Mean difference of changes of homocysteine level between 2 treatment groups

Secondary outcomes

  1. Serum Folate Level

    Time frame: 8 weeks

    correlation between serum folate and plasma homocysteine level

  2. Serum Vitamin B12 Level

    Time frame: 8 weeks

    correlation between serum vitamin B12 and plasma homocysteine level

Other outcomes

  1. Prevalence of Hyperhomocysteinemia

    Time frame: 8 weeks

    prevalence of hyperhomocysteinemia in Thai obese children

Sponsors and collaborators

Lead sponsor

Queen Sirikit National Institute of Child Health

Other Gov

Collaborators

  • Chulalongkorn University

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 11, 2013
Registry last updated
Dec 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.