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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
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Folic Acid
Hide Arm/Group Description

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

Folic Acid

Period Title: Overall Study
Started 24 26
Completed 23 23
Not Completed 1 3
Reason Not Completed
Lost to Follow-up             1             3
Arm/Group Title Placebo Folic Acid Total
Hide Arm/Group Description

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

Folic Acid

Total of all reporting groups
Overall Number of Baseline Participants 24 26 50
Hide Baseline Analysis Population Description
mean and SD
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 26 participants 50 participants
10.73  (1.64) 11.08  (1.57) 10.90  (1.60)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 26 participants 50 participants
Female
9
  37.5%
10
  38.5%
19
  38.0%
Male
15
  62.5%
16
  61.5%
31
  62.0%
1.Primary Outcome
Title Changes of Homocysteine Level
Hide Description Mean difference of changes of homocysteine level between 2 treatment groups
Time Frame 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Folic Acid
Hide Arm/Group Description:

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

Folic Acid

Overall Number of Participants Analyzed 23 23
Mean (Standard Deviation)
Unit of Measure: µmol/L
-0.68  (1.25) -1.35  (1.32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Folic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.68
Confidence Interval (2-Sided) 95%
-0.09 to 1.44
Parameter Dispersion
Type: Standard Deviation
Value: 1.3
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Serum Folate Level
Hide Description correlation between serum folate and plasma homocysteine level
Time Frame 8 weeks
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Serum Vitamin B12 Level
Hide Description correlation between serum vitamin B12 and plasma homocysteine level
Time Frame 8 weeks
Outcome Measure Data Not Reported
4.Other Pre-specified Outcome
Title Prevalence of Hyperhomocysteinemia
Hide Description prevalence of hyperhomocysteinemia in Thai obese children
Time Frame 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Folic Acid
Hide Arm/Group Description:

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

Folic Acid

Overall Number of Participants Analyzed 24 26
Measure Type: Number
Unit of Measure: participants
3 2
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Folic Acid
Hide Arm/Group Description

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

Folic Acid

All-Cause Mortality
Placebo Folic Acid
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Folic Acid
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/26 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Placebo Folic Acid
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/26 (0.00%) 
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
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