Phase 4
Completed N=50
Effect of Folic Acid Supplementation on Plasma Homocysteine Level in Obese Children
Hyperhomocysteinemia · Obesity
Source: ClinicalTrials.gov NCT01766310 ↗
Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Nov 2015
Primary outcomePrimary: Changes of Homocysteine Level — -0.68; -1.35 µmol/L — p=0.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes of Homocysteine Level |
-0.68; -1.35 | 0.05 |
| SECONDARY Serum Folate Level |
— | — |
| SECONDARY Serum Vitamin B12 Level |
— | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01766310). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.