Obesity Clinical Trial
Official title:
Effect of Folic Acid Supplementation on Plasma Homocysteine Level in Obese Children: a Randomized Double Blinded Placebo Controlled Trial
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Queen Sirikit National Institute of Child Health | Chulalongkorn University |
Thailand,
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
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 |
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