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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01766310
First Posted: January 11, 2013
Last Update Posted: December 11, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Chulalongkorn University
Information provided by (Responsible Party):
Pavinee Intakorn, Queen Sirikit National Institute of Child Health
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Pavinee Intakorn, Queen Sirikit National Institute of Child Health:

Primary Outcome Measures:
  • Changes of Homocysteine Level [ Time Frame: 8 weeks ]
    Mean difference of changes of homocysteine level between 2 treatment groups


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • Prevalence of Hyperhomocysteinemia [ Time Frame: 8 weeks ]
    prevalence of hyperhomocysteinemia in Thai obese children


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
yellow tablet contained 5mg of folic acid, manufactured from the Government Pharmaceutical Organization, Ministry of Public Health, Thailand

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

Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pavinee Intakorn, Queen Sirikit National Institute of Child Health
ClinicalTrials.gov Identifier: NCT01766310     History of Changes
Other Study ID Numbers: Folic-01
First Submitted: January 7, 2013
First Posted: January 11, 2013
Results First Submitted: August 10, 2014
Results First Posted: November 16, 2015
Last Update Posted: December 11, 2015
Last Verified: November 2015

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

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