Hyperhomocysteinemia, Obesity
Conditions
Keywords
Folic acid, Folate, Homocysteine, Obese, Children
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.
Interventions
DRUGFolic Acid
yellow tablet contained 5mg of folic acid, manufactured from the Government Pharmaceutical Organization, Ministry of Public Health, Thailand
DRUGplacebo
sugar tablet manufactured to mimic folic acid tablet
Sponsors
Chulalongkorn University
Queen Sirikit National Institute of Child Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
9 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of Homocysteine Level | 8 weeks | Mean difference of changes of homocysteine level between 2 treatment groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Folate Level | 8 weeks | correlation between serum folate and plasma homocysteine level |
| Serum Vitamin B12 Level | 8 weeks | correlation between serum vitamin B12 and plasma homocysteine level |
Other
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of Hyperhomocysteinemia | 8 weeks | prevalence of hyperhomocysteinemia in Thai obese children |
Countries
Thailand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 24 |
| Folic Acid Folic acid tablet 5mg per day orally (5mg/tablet) once a day for 8 weeks of the study
Folic Acid | 26 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 3 |
Baseline characteristics
| Characteristic | Placebo | Folic Acid | Total |
|---|---|---|---|
| Age, Continuous | 10.73 years STANDARD_DEVIATION 1.64 | 11.08 years STANDARD_DEVIATION 1.57 | 10.90 years STANDARD_DEVIATION 1.6 |
| Sex: Female, Male Female | 9 Participants | 10 Participants | 19 Participants |
| Sex: Female, Male Male | 15 Participants | 16 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 24 | 0 / 26 |
| serious Total, serious adverse events | 0 / 24 | 0 / 26 |
Outcome results
Primary
Changes of Homocysteine Level
Mean difference of changes of homocysteine level between 2 treatment groups
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Changes of Homocysteine Level | -0.68 µmol/L | Standard Deviation 1.25 |
| Folic Acid | Changes of Homocysteine Level | -1.35 µmol/L | Standard Deviation 1.32 |
p-value: 0.0595% CI: [-0.09, 1.44]t-test, 2 sided
Secondary
Serum Folate Level
correlation between serum folate and plasma homocysteine level
Time frame: 8 weeks
Secondary
Serum Vitamin B12 Level
correlation between serum vitamin B12 and plasma homocysteine level
Time frame: 8 weeks
Other Pre-specified
Prevalence of Hyperhomocysteinemia
prevalence of hyperhomocysteinemia in Thai obese children
Time frame: 8 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Prevalence of Hyperhomocysteinemia | 3 participants |
| Folic Acid | Prevalence of Hyperhomocysteinemia | 2 participants |