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

This study has been completed.
Sponsor:
Collaborator:
Chulalongkorn University
Information provided by (Responsible Party):
Orawan Iamopas, Queen Sirikit National Institute of Child Health
ClinicalTrials.gov Identifier:
NCT01766310
First received: January 7, 2013
Last updated: May 6, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Hyperhomocysteinemia
Obesity
Drug: Folic Acid
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Folic Acid Supplementation on Plasma Homocysteine Level in Obese Children: a Randomized Double Blinded Placebo Controlled Trial

Resource links provided by NLM:


Further study details as provided by Queen Sirikit National Institute of Child Health:

Primary Outcome Measures:
  • homocysteine level [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Mean difference of homocysteine level between 2 treatment groups


Secondary Outcome Measures:
  • Dietary folate level [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    correlation between dietary folate and plasma homocysteine level

  • serum folate level [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    correlation between serum folate and plasma homocysteine level

  • serum vitamin B12 level [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    correlation between serum vitamin B12 and plasma homocysteine level


Other Outcome Measures:
  • prevalence of hyperhomocysteinemia [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    prevalence of hyperhomocysteinemia


Enrollment: 50
Study Start Date: December 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo
placebo tablet in the same appearance and taste with folic acid orally once a day for 8 weeks of the study
Drug: placebo
sugar tablet manufactured to mimic folic acid tablet
Experimental: folic acid
Folic acid tablet 5mg per day orally (5mg/tablet) once a day for 8 weeks of the study
Drug: Folic Acid

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.

  Eligibility

Ages Eligible for Study:   9 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01766310

Locations
Thailand
Department of Pediatrics, Queen Sirikit National Institute of Child Health
Bangkok, Thailand, 10400
Queen Sirikit National Institute of Child Health
Bangkok, Thailand, 10400
Sponsors and Collaborators
Queen Sirikit National Institute of Child Health
Chulalongkorn University
Investigators
Principal Investigator: Orawan Iamopas, MD. Queen Sirikit National Institute of Child Health
  More Information

Publications:
Responsible Party: Orawan Iamopas, Queen Sirikit National Institute of Child Health
ClinicalTrials.gov Identifier: NCT01766310     History of Changes
Other Study ID Numbers: Folic-01
Study First Received: January 7, 2013
Last Updated: May 6, 2013
Health Authority: Thailand: Ministry of Public Health

Keywords provided by Queen Sirikit National Institute of Child Health:
Folic acid
Folate
Homocysteine
Obese
Children

Additional relevant MeSH terms:
Hyperhomocysteinemia
Amino Acid Metabolism, Inborn Errors
Avitaminosis
Deficiency Diseases
Genetic Diseases, Inborn
Malabsorption Syndromes
Malnutrition
Metabolic Diseases
Metabolism, Inborn Errors
Nutrition Disorders
Vitamin B Deficiency
Folic Acid
Vitamin B Complex
Growth Substances
Hematinics
Hematologic Agents
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vitamins

ClinicalTrials.gov processed this record on October 20, 2014