Clinical trial NCT01766310: Effect of Folic Acid Supplementation on Plasma Homocysteine Level in Obese Children
Official title: Effect of Folic Acid Supplementation on Plasma Homocysteine Level in Obese Children: a Randomized Double Blinded Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hyperhomocysteinemia
Obesity
Keywords: Folic acid
Folate
Homocysteine
Obese
Children
Lead sponsor: Queen Sirikit National Institute of Child Health
Sponsor class: OTHER_GOV
Collaborators: name: Chulalongkorn University
First posted: 2013-01-11
Enrollment: 50
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes of Homocysteine Level
timeFrame: 8 weeks
Secondary outcomes:
measure: Serum Folate Level
timeFrame: 8 weeks
measure: Serum Vitamin B12 Level
timeFrame: 8 weeks
Other outcomes:
measure: Prevalence of Hyperhomocysteinemia
timeFrame: 8 weeks
Locations:
city: Bangkok
country: Thailand
facility: Department of Pediatrics, Queen Sirikit National Institute of Child Health
city: Bangkok
country: Thailand
facility: Queen Sirikit National Institute of Child Health
Study officials:
affiliation: Queen Sirikit National Institute of Child Health
name: Orawan Iamopas, MD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Solini A, Santini E, Ferrannini E. Effect of short-term folic acid supplementation on insulin sensitivity and inflammatory markers in overweight subjects. Int J Obes (Lond). 2006 Aug;30(8):1197-202. doi: 10.1038/sj.ijo.0803265. Epub 2006 Feb 21.
citation: Papandreou D, Malindretos P, Arvanitidou M, Makedou A, Rousso I. Oral supplementation of folic acid for two months reduces total serum homocysteine levels in hyperhomocysteinemic Greek children. Hippokratia. 2010 Apr;14(2):105-8.
citation: Papandreou D, Malindretos P, Arvanitidou M, Makedou A, Rousso I. Homocysteine lowering with folic acid supplements in children: effects on blood pressure. Int J Food Sci Nutr. 2010 Feb;61(1):11-7. doi: 10.3109/09637480903286371.
citation: Pena AS, Wiltshire E, Gent R, Hirte C, Couper J. Folic acid improves endothelial function in children and adolescents with type 1 diabetes. J Pediatr. 2004 Apr;144(4):500-4. doi: 10.1016/j.jpeds.2003.12.049.
citation: Gargari BP, Aghamohammadi V, Aliasgharzadeh A. Effect of folic acid supplementation on biochemical indices in overweight and obese men with type 2 diabetes. Diabetes Res Clin Pract. 2011 Oct;94(1):33-8. doi: 10.1016/j.diabres.2011.07.003. Epub 2011 Jul 28.
citation: Iamopas O, Ratanachu-ek S, Chomtho S. Effect of folic acid supplementation on plasma homocysteine in obese children: a randomized, double-blind, placebo-controlled trial. J Med Assoc Thai. 2014 Jun;97 Suppl 6:S195-204.