Effect of Folic Acid Supplementation on Plasma Homocysteine Level in Obese Children
Primary Purpose
Hyperhomocysteinemia, Obesity
Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Folic Acid
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hyperhomocysteinemia focused on measuring Folic acid, Folate, Homocysteine, Obese, Children
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
Sites / Locations
- Department of Pediatrics, Queen Sirikit National Institute of Child Health
- Queen Sirikit National Institute of Child Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
placebo
folic acid
Arm Description
placebo tablet in the same appearance and taste with folic acid orally once a day for 8 weeks of the study
Folic acid tablet 5mg per day orally (5mg/tablet) once a day for 8 weeks of the study
Outcomes
Primary Outcome Measures
Changes of Homocysteine Level
Mean difference of changes of homocysteine level between 2 treatment groups
Secondary Outcome Measures
Serum Folate Level
correlation between serum folate and plasma homocysteine level
Serum Vitamin B12 Level
correlation between serum vitamin B12 and plasma homocysteine level
Full Information
NCT ID
NCT01766310
First Posted
January 7, 2013
Last Updated
November 16, 2015
Sponsor
Queen Sirikit National Institute of Child Health
Collaborators
Chulalongkorn University
1. Study Identification
Unique Protocol Identification Number
NCT01766310
Brief Title
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
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen Sirikit National Institute of Child Health
Collaborators
Chulalongkorn University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperhomocysteinemia, Obesity
Keywords
Folic acid, Folate, Homocysteine, Obese, Children
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo tablet in the same appearance and taste with folic acid orally once a day for 8 weeks of the study
Arm Title
folic acid
Arm Type
Experimental
Arm Description
Folic acid tablet 5mg per day orally (5mg/tablet) once a day for 8 weeks of the study
Intervention Type
Drug
Intervention Name(s)
Folic Acid
Intervention Description
yellow tablet contained 5mg of folic acid, manufactured from the Government Pharmaceutical Organization, Ministry of Public Health, Thailand
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
sugar tablet manufactured to mimic folic acid tablet
Primary Outcome Measure Information:
Title
Changes of Homocysteine Level
Description
Mean difference of changes of homocysteine level between 2 treatment groups
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Serum Folate Level
Description
correlation between serum folate and plasma homocysteine level
Time Frame
8 weeks
Title
Serum Vitamin B12 Level
Description
correlation between serum vitamin B12 and plasma homocysteine level
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Prevalence of Hyperhomocysteinemia
Description
prevalence of hyperhomocysteinemia in Thai obese children
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Orawan Iamopas, MD.
Organizational Affiliation
Queen Sirikit National Institute of Child Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pediatrics, Queen Sirikit National Institute of Child Health
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Queen Sirikit National Institute of Child Health
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
12. IPD Sharing Statement
Citations:
PubMed Identifier
16491109
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.
Results Reference
background
PubMed Identifier
20596265
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.
Results Reference
background
PubMed Identifier
19939196
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.
Results Reference
background
PubMed Identifier
15069400
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.
Results Reference
background
PubMed Identifier
21802161
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.
Results Reference
background
PubMed Identifier
25391194
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.
Results Reference
derived
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Effect of Folic Acid Supplementation on Plasma Homocysteine Level in Obese Children
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