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

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ClinicalTrials.gov Identifier: NCT01766310
Recruitment Status : Completed
First Posted : January 11, 2013
Results First Posted : November 16, 2015
Last Update Posted : December 11, 2015
Sponsor:
Collaborator:
Chulalongkorn University
Information provided by (Responsible Party):
Pavinee Intakorn, Queen Sirikit National Institute of Child Health

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Hyperhomocysteinemia
Obesity
Interventions: Drug: Folic Acid
Drug: placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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

Folic Acid

Folic acid tablet 5mg per day orally (5mg/tablet) once a day for 8 weeks of the study

Folic Acid


Participant Flow:   Overall Study
    Placebo   Folic Acid
STARTED   24   26 
COMPLETED   23   23 
NOT COMPLETED   1   3 
Lost to Follow-up                1                3 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
mean and SD

Reporting Groups
  Description
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

Folic Acid

Folic acid tablet 5mg per day orally (5mg/tablet) once a day for 8 weeks of the study

Folic Acid

Total Total of all reporting groups

Baseline Measures
   Placebo   Folic Acid   Total 
Overall Participants Analyzed 
[Units: Participants]
 24   26   50 
Age 
[Units: Years]
Mean (Standard Deviation)
 10.73  (1.64)   11.08  (1.57)   10.90  (1.60) 
Gender 
[Units: Participants]
     
Female   9   10   19 
Male   15   16   31 


  Outcome Measures

1.  Primary:   Changes of Homocysteine Level   [ Time Frame: 8 weeks ]

2.  Other Pre-specified:   Prevalence of Hyperhomocysteinemia   [ Time Frame: 8 weeks ]

3.  Secondary:   Serum Folate Level   [ Time Frame: 8 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Serum Vitamin B12 Level   [ Time Frame: 8 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Orawan Iamopas
Organization: Queen Sirikit National Institute of Child Health
phone: 66-2-354-8415 ext 3327
e-mail: orawaneamopas@yahoo.com


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