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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effect of Folic Acid Supplementation on Plasma Homocysteine Level in Obese Children: a Randomized Double Blinded Placebo Controlled Trial

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 Summary:

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.


Sponsor: Queen Sirikit National Institute of Child Health

Current Primary Outcome: Changes of Homocysteine Level [ Time Frame: 8 weeks ]

Mean difference of changes of homocysteine level between 2 treatment groups


Original Primary Outcome: homocysteine level [ Time Frame: 8 weeks ]

Mean difference of homocysteine level between 2 treatment groups


Current Secondary Outcome:

  • Serum Folate Level [ Time Frame: 8 weeks ]
    correlation between serum folate and plasma homocysteine level
  • Serum Vitamin B12 Level [ Time Frame: 8 weeks ]
    correlation between serum vitamin B12 and plasma homocysteine level


Original Secondary Outcome:

  • Dietary folate level [ Time Frame: 8 weeks ]
    correlation between dietary folate and plasma homocysteine level
  • Serum Folate Level [ Time Frame: 8 weeks ]
    correlation between serum folate and plasma homocysteine level
  • Serum Vitamin B12 Level [ Time Frame: 8 weeks ]
    correlation between serum vitamin B12 and plasma homocysteine level


Information By: Queen Sirikit National Institute of Child Health

Dates:
Date Received: January 7, 2013
Date Started: December 2012
Date Completion:
Last Updated: November 16, 2015
Last Verified: November 2015