Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Chulalongkorn University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | placebo tablet in the same appearance and taste with folic acid orally once a day for 8 weeks of the study |
|
| folic acid | Experimental | Folic acid tablet 5mg per day orally (5mg/tablet) once a day for 8 weeks of the study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Folic Acid | Drug | yellow tablet contained 5mg of folic acid, manufactured from the Government Pharmaceutical Organization, Ministry of Public Health, Thailand |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes of Homocysteine Level | Mean difference of changes of homocysteine level between 2 treatment groups | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Folate Level | correlation between serum folate and plasma homocysteine level | 8 weeks |
| Serum Vitamin B12 Level | correlation between serum vitamin B12 and plasma homocysteine level |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of Hyperhomocysteinemia | prevalence of hyperhomocysteinemia in Thai obese children | 8 weeks |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Orawan Iamopas, MD. | Queen Sirikit National Institute of Child Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pediatrics, Queen Sirikit National Institute of Child Health | Bangkok | Bangkok | 10400 | Thailand | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16491109 | Background | 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. | |
| 20596265 | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | placebo tablet in the same appearance and taste with folic acid orally once a day for 8 weeks of the study placebo: sugar tablet manufactured to mimic folic acid tablet |
| FG001 | Folic Acid | Folic acid tablet 5mg per day orally (5mg/tablet) once a day for 8 weeks of the study Folic Acid |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
mean and SD
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | placebo tablet in the same appearance and taste with folic acid orally once a day for 8 weeks of the study placebo: sugar tablet manufactured to mimic folic acid tablet |
| BG001 | Folic Acid |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes of Homocysteine Level | Mean difference of changes of homocysteine level between 2 treatment groups | Posted | Mean | Standard Deviation | µmol/L | 8 weeks |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | placebo tablet in the same appearance and taste with folic acid orally once a day for 8 weeks of the study placebo: sugar tablet manufactured to mimic folic acid tablet |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Orawan Iamopas | Queen Sirikit National Institute of Child Health | 66-2-354-8415 | 3327 | orawaneamopas@yahoo.com |
Not provided
| ID | Term |
|---|---|
| D020138 | Hyperhomocysteinemia |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D000592 | Amino Acid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided
| ID | Term |
|---|---|
| D005492 | Folic Acid |
| ID | Term |
|---|---|
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| placebo | Drug | sugar tablet manufactured to mimic folic acid tablet |
|
| 8 weeks |
| Queen Sirikit National Institute of Child Health |
| Bangkok |
| Bangkok |
| 10400 |
| Thailand |
| 19939196 | 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. |
| 15069400 | 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. |
| 21802161 | 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. |
| 25391194 | Derived | 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. |
Folic acid tablet 5mg per day orally (5mg/tablet) once a day for 8 weeks of the study
Folic Acid
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Secondary | Serum Folate Level | correlation between serum folate and plasma homocysteine level | Not Posted | 8 weeks |
| Secondary | Serum Vitamin B12 Level | correlation between serum vitamin B12 and plasma homocysteine level | Not Posted | 8 weeks |
| Other Pre-specified | Prevalence of Hyperhomocysteinemia | prevalence of hyperhomocysteinemia in Thai obese children | Posted | Number | participants | 8 weeks |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Folic Acid | Folic acid tablet 5mg per day orally (5mg/tablet) once a day for 8 weeks of the study Folic Acid | 0 | 26 | 0 | 26 |
Not provided
Not provided
| D008286 | Malabsorption Syndromes |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D014804 | Vitamin B Deficiency |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 | Heterocyclic Compounds |