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

• Sponsor: Queen Sirikit National Institute of Child Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT01766310
• Collaborator: Chulalongkorn University (Other)
• Enrollment: 50
• Locations: 2
• Arms: 2
• Duration (Months): 3
• Patients Per Site: 25
• Patients Per Site Per Month: 8.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hyperhomocysteinemia; Obesity	Drug: Folic Acid; Drug: placebo	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• 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
• Study Start Date: Dec 1, 2012
• Actual Primary Completion Date: Mar 1, 2013
• Actual Study Completion Date: Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Changes of Homocysteine Level [8 weeks]

   Mean difference of changes of homocysteine level between 2 treatment groups

Secondary Outcome Measures

1. Serum Folate Level [8 weeks]

   correlation between serum folate and plasma homocysteine level

2. Serum Vitamin B12 Level [8 weeks]

   correlation between serum vitamin B12 and plasma homocysteine level

Other Outcome Measures

1. Prevalence of Hyperhomocysteinemia [8 weeks]

   prevalence of hyperhomocysteinemia in Thai obese children

Eligibility Criteria

Criteria

• Ages Eligible for Study: 9 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Department of Pediatrics, Queen Sirikit National Institute of Child Health	Bangkok		Thailand	10400
2	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

Study Documents (Full-Text)

None provided.

More Information

Publications

• Gargari BP, Aghamohammadi V, Aliasgharzadeh A. Effect of folic acid supplementation on biochemical indices in overweight and obese men with type 2 diabetes. Diabetes Res Clin Pract. 2011 Oct;94(1):33-8. doi: 10.1016/j.diabres.2011.07.003. Epub 2011 Jul 28.
• Papandreou D, Malindretos P, Arvanitidou M, Makedou A, Rousso I. Homocysteine lowering with folic acid supplements in children: effects on blood pressure. Int J Food Sci Nutr. 2010 Feb;61(1):11-7. doi: 10.3109/09637480903286371.
• Papandreou D, Malindretos P, Arvanitidou M, Makedou A, Rousso I. Oral supplementation of folic acid for two months reduces total serum homocysteine levels in hyperhomocysteinemic Greek children. Hippokratia. 2010 Apr;14(2):105-8.
• Peña AS, Wiltshire E, Gent R, Hirte C, Couper J. Folic acid improves endothelial function in children and adolescents with type 1 diabetes. J Pediatr. 2004 Apr;144(4):500-4.
• Solini A, Santini E, Ferrannini E. Effect of short-term folic acid supplementation on insulin sensitivity and inflammatory markers in overweight subjects. Int J Obes (Lond). 2006 Aug;30(8):1197-202. Epub 2006 Feb 21.

• Responsible Party: Pavinee Intakorn, Queen Sirikit National Institute of Child Health, Queen Sirikit National Institute of Child Health
• ClinicalTrials.gov Identifier: NCT01766310
• Other Study ID Numbers: Folic-01
• First Posted: Jan 11, 2013
• Last Update Posted: Dec 11, 2015
• Last Verified: Nov 1, 2015

• Keywords provided by Pavinee Intakorn, Queen Sirikit National Institute of Child Health, Queen Sirikit National Institute of Child Health: Folic acid; Folate; Homocysteine; Obese; Children
• Additional relevant MeSH terms: Hyperhomocysteinemia; Folic Acid

Study Results

Participant Flow

Arm/Group Title	Placebo	Folic Acid
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

Baseline Characteristics

Arm/Group Title	Placebo	Folic Acid	Total
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 Participants	24	26	50
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	10.73 (1.64)	11.08 (1.57)	10.90 (1.60)
Sex: Female, Male (Count of Participants)
Female	9 37.5%	10 38.5%	19 38%
Male	15 62.5%	16 61.5%	31 62%

Outcome Measures

1. Primary Outcome

Title	Changes of Homocysteine Level
Description	Mean difference of changes of homocysteine level between 2 treatment groups
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Folic Acid
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
Measure Participants	23	23
Mean (Standard Deviation) [µmol/L]	-0.68 (1.25)	-1.35 (1.32)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Folic Acid
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	t-test, 2 sided
	Comments
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

2. Secondary Outcome

Title	Serum Folate Level
Description	correlation between serum folate and plasma homocysteine level
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Serum Vitamin B12 Level
Description	correlation between serum vitamin B12 and plasma homocysteine level
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Other Pre-specified Outcome

Title	Prevalence of Hyperhomocysteinemia
Description	prevalence of hyperhomocysteinemia in Thai obese children
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Folic Acid
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
Measure Participants	24	26
Number [participants]	3 12.5%	2 7.7%

Adverse Events

Arm/Group Title	Placebo		Folic Acid
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		Folic Acid
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/26 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		Folic Acid
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/26 (0%)

Limitations/Caveats

[Not Specified]

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.