HyperhomocysteinemiaPhase 4NCT01766310
Effect of Folic Acid Supplementation on Plasma Homocysteine Level in Obese Children
A Phase 4 study testing Folic Acid in people with Hyperhomocysteinemia and Obesity, run by Queen Sirikit National Institute of Child Health at 2 sites in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 18 years
- Conditions the study is for
- Hyperhomocysteinemia, Obesity
- What is being tested?
- Folic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesThailand
- Study dates
- Dec 2012to Mar 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites
Department of Pediatrics, Queen Sirikit National Institute of Child Health
Bangkok, Bangkok, 10400
Queen Sirikit National Institute of Child Health
Bangkok, Bangkok, 10400
About this study
Official title: Effect of Folic Acid Supplementation on Plasma Homocysteine Level in Obese Children: a Randomized Double Blinded Placebo Controlled Trial
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.
Read the 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.
- Conditions
- Hyperhomocysteinemia, Obesity
- Being tested
- Folic Acid, placebo
- Keywords
- Folic acid, Folate, Homocysteine, Obese, Children
- Medical subject headings
- Hyperhomocysteinemia, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Folic AcidDrug
yellow tablet contained 5mg of folic acid, manufactured from the Government Pharmaceutical Organization, Ministry of Public Health, Thailand
placeboDrug
sugar tablet manufactured to mimic folic acid tablet
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | placebo tablet in the same appearance and taste with folic acid orally once a day for 8 weeks of the study Receives: Drug: placebo |
| folic acid | Experimental | Folic acid tablet 5mg per day orally (5mg/tablet) once a day for 8 weeks of the study Receives: Drug: Folic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Homocysteine Level
Mean difference of changes of homocysteine level between 2 treatment groups
Measured: 8 weeks
Secondary outcomes (2)
Serum Folate Level
correlation between serum folate and plasma homocysteine level
Measured: 8 weeks
Serum Vitamin B12 Level
correlation between serum vitamin B12 and plasma homocysteine level
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HyperhomocysteinemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Sirikit National Institute of Child Health
- Sponsor type
- Other government
- Collaborators
- Chulalongkorn University
- Responsible party
- Principal investigator, Pavinee Intakorn, Queen Sirikit National Institute of Child Health
- Investigators
- Orawan Iamopas, MD., Principal investigator, Queen Sirikit National Institute of Child Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01766310
- Sponsor's protocol ID
- Folic-01
- Status last verified
- Nov 2015
- First submitted
- 7 Jan 2013
- Last updated
- 11 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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. doi: 10.1038/sj.ijo.0803265. Epub 2006 Feb 21.
PubMed 16491109Papandreou 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.
PubMed 20596265Papandreou 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.
PubMed 19939196Pena 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. doi: 10.1016/j.jpeds.2003.12.049.
PubMed 15069400Gargari 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.
PubMed 21802161Iamopas O, Ratanachu-ek S, Chomtho S. Effect of folic acid supplementation on plasma homocysteine in obese children: a randomized, double-blind, placebo-controlled trial. J Med Assoc Thai. 2014 Jun;97 Suppl 6:S195-204.
PubMed 25391194
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Folic Acid Supplementation on Plasma Homocysteine Level in Obese Children: a Randomized Double Blinded Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT01766310
- Acronym / sponsor ID
- Folic-01
- Conditions
- Hyperhomocysteinemia, Obesity
- Keywords
- Folic acid, Folate, Homocysteine, Obese, Children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Queen Sirikit National Institute of Child HealthOther government
- Collaborators
- Chulalongkorn University
- Study start
- Dec 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 11 Jan 2013 (estimated)
- Results
- Posted 16 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: placeboplacebo tablet in the same appearance and taste with folic acid orally once a day for 8 weeks of the study |
| folic acid | Experimental | Drug: Folic AcidFolic acid tablet 5mg per day orally (5mg/tablet) once a day for 8 weeks of the study |
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Folic Acidyellow tablet contained 5mg of folic acid, manufactured from the Government Pharmaceutical Organization, Ministry of Public Health, Thailand | Drug | folic acid |
| placebosugar tablet manufactured to mimic folic acid tablet | Drug | placebo |
Primary outcome
Changes of Homocysteine Level
Time frame: 8 weeks
Mean difference of changes of homocysteine level between 2 treatment groups
2 secondary outcomes
Serum Folate Level
Time frame: 8 weeks
Serum Vitamin B12 Level
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16491109Solini 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. doi: 10.1038/sj.ijo.0803265. Epub 2006 Feb 21.
- Background: PubMed 20596265Papandreou 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.
- Background: PubMed 19939196Papandreou 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.
- Background: PubMed 15069400Pena 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. doi: 10.1016/j.jpeds.2003.12.049.
- Background: PubMed 21802161Gargari 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.
- Derived from this study: PubMed 25391194Iamopas O, Ratanachu-ek S, Chomtho S. Effect of folic acid supplementation on plasma homocysteine in obese children: a randomized, double-blind, placebo-controlled trial. J Med Assoc Thai. 2014 Jun;97 Suppl 6:S195-204.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Orawan Iamopas, MD. principal investigator
Queen Sirikit National Institute of Child Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Folic Acid in people with Hyperhomocysteinemia and Obesity, run by Queen Sirikit National Institute of Child Health at 2 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of Homocysteine Level (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01766310, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2015.