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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01766310
• Other study ID #: Folic-01
• Status: Completed
• Phase: Phase 4
• First received: January 7, 2013
• Last updated: November 16, 2015
• Start date: December 2012
• Est. completion date: March 2013

Study information

• Verified date: November 2015
• Source: Queen Sirikit National Institute of Child Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperhomocysteinemia
• Obesity

Intervention

Drug:
• Folic Acid
yellow tablet contained 5mg of folic acid, manufactured from the Government Pharmaceutical Organization, Ministry of Public Health, Thailand
• placebo
sugar tablet manufactured to mimic folic acid tablet

Locations

Country	Name	City	State
Thailand	Department of Pediatrics, Queen Sirikit National Institute of Child Health	Bangkok
Thailand	Queen Sirikit National Institute of Child Health	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Queen Sirikit National Institute of Child Health	Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

References & Publications (5)

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. — View 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. — View 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. — View Citation

Peña 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. — View 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. Epub 2006 Feb 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Prevalence of Hyperhomocysteinemia	prevalence of hyperhomocysteinemia in Thai obese children	8 weeks	No
Primary	Changes of Homocysteine Level	Mean difference of changes of homocysteine level between 2 treatment groups	8 weeks	No
Secondary	Serum Folate Level	correlation between serum folate and plasma homocysteine level	8 weeks	No
Secondary	Serum Vitamin B12 Level	correlation between serum vitamin B12 and plasma homocysteine level	8 weeks	No