A Phase 4 interventional study of Folic Acid and placebo in Hyperhomocysteinemia and Obesity, sponsored by Queen Sirikit National Institute of Child Health. Completed at 2 sites in Thailand. Open to participants aged 9 Years to 18 Years. Per ClinicalTrials.gov, last updated 2015-12-11.
Sponsored by Queen Sirikit National Institute of Child Health · Phase 4, Interventional, and Treatment
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.
34 studies on the registry are indexed under Hyperhomocysteinemia; 4 are open to participants now.
This study's enrollment of 50 is below the median of 84 across 21 interventional studies indexed under Hyperhomocysteinemia.
Browse Hyperhomocysteinemia studies →Queen Sirikit National Institute of Child Health is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 tablet 5mg per day orally (5mg/tablet) once a day for 8 weeks of the study
Drug: Folic Acid
yellow tablet contained 5mg of folic acid, manufactured from the Government Pharmaceutical Organization, Ministry of Public Health, Thailand
sugar tablet manufactured to mimic folic acid tablet
Changes of Homocysteine Level
Mean difference of changes of homocysteine level between 2 treatment groups
Time frame: 8 weeks
Serum Folate Level
correlation between serum folate and plasma homocysteine level
Time frame: 8 weeks
Serum Vitamin B12 Level
correlation between serum vitamin B12 and plasma homocysteine level
Time frame: 8 weeks
Prevalence of Hyperhomocysteinemia
prevalence of hyperhomocysteinemia in Thai obese children
Time frame: 8 weeks
| Milestone | Placebo | Folic Acid |
|---|---|---|
| Started | 24 | 26 |
| Completed | 23 | 23 |
| Not completed | 1 | 3 |
| Withdrew: Lost to follow-up | 1 | 3 |
Mean difference of changes of homocysteine level between 2 treatment groups
| µmol/L | Placebo | Folic Acid |
|---|---|---|
| Changes of Homocysteine Level | -0.68 ± 1.25 | -1.35 ± 1.32 |
correlation between serum folate and plasma homocysteine level
Results for this outcome have not been posted.
correlation between serum vitamin B12 and plasma homocysteine level
Results for this outcome have not been posted.
prevalence of hyperhomocysteinemia in Thai obese children
| participants | Placebo | Folic Acid |
|---|---|---|
| Prevalence of Hyperhomocysteinemia | 3 | 2 |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 0/24 (0%) | 0/24 (0%) |
| Folic Acid | — | 0/26 (0%) | 0/26 (0%) |
mean and SD
| Age, Continuous(years) | Placebo | Folic Acid | Total |
|---|---|---|---|
| Mean | 10.73 ± 1.64 | 11.08 ± 1.57 | 10.90 ± 1.60 |
| Sex: Female, Male(Participants) | Placebo | Folic Acid | Total |
|---|---|---|---|
| Female | 9 | 10 | 19 |
| Male | 15 | 16 | 31 |
The record gives a start of Dec 2012, a primary completion of Mar 2013 and a completion of Mar 2013. It does not say whether these dates are actual or estimated.
Results were first posted in Nov 2015, 2 years 8 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Folic Acid
Queen Sirikit National Institute of Child Health