Related Experiment Video
Updated: Feb 12, 2026

Author Spotlight: Evaluating the Adjuvant Efficacy and Safety of Angong Niuhuang Pill in Viral Encephalitis Treatment
Published on: April 19, 2024
Prophylactic effect of riboflavin on pediatric migraine: a randomized, double-blind, placebo-controlled trial
Ahmad Talebian1,2, Babak Soltani2,3, Hamid Reza Banafshe4
1M.D., Pediatric Neurologist, Professor, Department of Pediatrics, Faculty of Medicine, Kashan University of Medical Sciences, Kashan, Iran.
Insights
High-dose riboflavin significantly reduced migraine frequency and duration in children. Low-dose riboflavin showed no significant effect, indicating high-dose is a safe prophylactic option for pediatric migraine.
Area of Science:
- Pediatric Neurology
- Clinical Trial Research
- Migraine Prophylaxis
Background:
- Migraine is a common neurological disorder in children.
- Prophylactic treatments aim to reduce migraine frequency, intensity, and duration.
- Riboflavin (vitamin B2) is investigated for its potential prophylactic effects.
Purpose of the Study:
- To evaluate the prophylactic efficacy of riboflavin in children suffering from migraine.
- To compare the effects of low-dose and high-dose riboflavin against a placebo.
Main Methods:
- A randomized clinical trial involving 90 children with migraine.
- Participants were assigned to placebo, low-dose riboflavin, or high-dose riboflavin groups.
- Outcomes (frequency, intensity, duration) were assessed at baseline and 12 weeks.
Main Results:
- High-dose riboflavin significantly decreased migraine frequency and duration compared to placebo (p=0.000).
- Low-dose riboflavin did not show significant reductions in frequency or duration versus placebo.
- Neither low-dose nor high-dose riboflavin significantly reduced migraine intensity.
Conclusions:
- High-dose riboflavin is a safe and effective prophylactic treatment for pediatric migraine.
- It is well-tolerated and cost-effective for managing childhood migraines.
- Further research may explore optimal dosing for intensity reduction.
Background And Aim:
Riboflavin may have an acceptable effect on migraine among children. This study was carried out to determine the prophylactic effect of riboflavin on migraine in children.
Methods:
This randomized clinical trial study was performed at Shahid Beheshti Hospital in Kashan, Iran from December 2012 to February 2015. Ninety children with migraine were allocated randomly into 3 groups (placebo, low-dose and high-dose riboflavin). The outcomes (frequency, intensity and duration of headaches) were measured at baseline and 12 weeks of medication in each group, and the decrease of them were compared. SPSS software version 16 was used for analysis of the data. Descriptive statistics, Chi-square, Fisher's exact and t-test were used for statistical analyses.
Results:
There was a significant decrease of migraine frequency (p=0.000) and mean duration (p=0.000) in the high-dose group compared with the placebo group. No significant reduction of frequency and mean duration of attacks were reported in the low-dose group compared to the placebo group (p=0.49 and p=0.69 respectively). There was no significant reduction of migraine intensity in the low-dose and high-dose groups compared to the placebo group (p=0.71 and p=0.74 respectively).
Conclusion:
High-dose riboflavin is a safe, well tolerated, cost-effective method of prophylaxis for children with migraine.
Trial Registration:
The trial was registered at the Iranian Clinical Trial Registry with number IRCT2013020412361N1.
Funding:
The study was supported by the Deputy of Research, Kashan University of Medical Sciences (grant number 91073).
More Related Videos
08:53Randomized, Triple-Blind, and Parallel-Controlled Trial of Transcranial Direct Current Stimulation for Cognitive Rehabilitation after Stroke
Published on: June 6, 2025
03:26Author Spotlight: Advancements and Challenges in Surgical Treatments for Postamputation Pain
Published on: March 8, 2024
Related Concept Videos
Blind Procedures
The Placebo Effect
Blinding
Trial and Error and Algorithm
Clinical Trials: Overview
Clinical Trials
There are four phases in a clinical trial. A phase one...