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

NCT ID: NCT01766310

Last Updated: 2015-12-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-03-31

Brief Summary

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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

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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

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Hyperhomocysteinemia Obesity

Keywords

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Folic acid Folate Homocysteine Obese Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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placebo

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

sugar tablet manufactured to mimic folic acid tablet

folic acid

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

Group Type EXPERIMENTAL

Folic Acid

Intervention Type DRUG

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

Interventions

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Folic Acid

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

Intervention Type DRUG

placebo

sugar tablet manufactured to mimic folic acid tablet

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

9 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chulalongkorn University

OTHER

Sponsor Role collaborator

Queen Sirikit National Institute of Child Health

OTHER_GOV

Sponsor Role lead

Responsible Party

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Pavinee Intakorn

Queen Sirikit National Institute of Child Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Orawan Iamopas, MD.

Role: PRINCIPAL_INVESTIGATOR

Queen Sirikit National Institute of Child Health

Locations

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Department of Pediatrics, Queen Sirikit National Institute of Child Health

Bangkok, Bangkok, Thailand

Site Status

Queen Sirikit National Institute of Child Health

Bangkok, Bangkok, Thailand

Site Status

Countries

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Thailand

References

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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.

Reference Type BACKGROUND
PMID: 16491109 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20596265 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19939196 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15069400 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21802161 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25391194 (View on PubMed)

Other Identifiers

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Folic-01

Identifier Type: -

Identifier Source: org_study_id