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

NCT01766310 | Completed Phase 4 Results

• 1 other identifier: Folic-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Hyperhomocysteinemia; Obesity

Keywords

Folic acid; Folate; Homocysteine; Obese; Children

Outcome Measures

Primary Outcomes (1)

• Changes of Homocysteine Level

  Mean difference of changes of homocysteine level between 2 treatment groups

  8 weeks

Secondary Outcomes (2)

• Serum Folate Level

  8 weeks

• Serum Vitamin B12 Level

  8 weeks

Other Outcomes (1)

• Prevalence of Hyperhomocysteinemia

  8 weeks

Study Arms (2)

placebo

PLACEBO COMPARATOR

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

Drug: placebo

folic acid

EXPERIMENTAL

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

Drug: Folic Acid

Interventions

Folic Acid DRUG

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

folic acid

placebo DRUG

sugar tablet manufactured to mimic folic acid tablet

placebo

Eligibility Criteria

• Age: 9 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen Sirikit National Institute of Child Health: lead
• Chulalongkorn University: collaborator

Study Sites (2)

Department of Pediatrics, Queen Sirikit National Institute of Child Health

Bangkok, Bangkok, 10400, Thailand

Location

Queen Sirikit National Institute of Child Health

Bangkok, Bangkok, 10400, Thailand

Location

Related Publications (6)

• 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.

  PMID: 16491109 BACKGROUND

• 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.

  PMID: 20596265 BACKGROUND

• 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.

  PMID: 19939196 BACKGROUND

• 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.

  PMID: 15069400 BACKGROUND

• 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.

  PMID: 21802161 BACKGROUND

• 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.

  PMID: 25391194 DERIVED

MeSH Terms

Conditions

Hyperhomocysteinemia; Obesity

Interventions

Folic Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Orawan Iamopas
• Organization: Queen Sirikit National Institute of Child Health

orawaneamopas@yahoo.com

66-2-354-8415

Study Officials

• Orawan Iamopas, MD.

  Queen Sirikit National Institute of Child Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Queen Sirikit National Institute of Child Health

Study Record Dates

• First Submitted: January 7, 2013
• First Posted: January 11, 2013
• Study Start: December 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: December 11, 2015
• Results First Posted: November 16, 2015

Record last verified: 2015-11

Locations

TH (2)