The effect of wheat germ oil on vitamin D levels and changes in liver enzymes in children

The effect of wheat germ oil on vitamin D levels and changes in liver enzymes in children 2 to 12 years old treated with phenobarbital and sodium valproate referred to Imam Ali Clinic in Shahrekord

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210319050742N1

Enrollment

120

Registered

2021-06-04

Start date

2021-06-22

Completion date

Unknown

Last updated

2021-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children treated with phenobarbital and sodium valproate. Epilepsy and recurrent seizures

Interventions

Intervention 1: Control group: Group 2: Phenobarbital + Vitamin D + Placebo. Intervention 2: Intervention group: Group 1: Phenobarbital + Vitamin D + Wheat germ oil. Intervention 3: Control group: Gro

Eligibility

Sex/Gender

All

Age

2 Years to 12 Years

Inclusion criteria

Inclusion criteria: Definitive diagnosis of epilepsy Has an age of 2 to 12 years Lack of underlying disease that affects the metabolism of vitamin D and calcium Do not take drugs or drugs that affect the metabolism of calcium and vitamin D. Do not receive oral or injectable vitamin compounds containing vitamin D in the last 3 months. Do not suffer from acute and chronic liver diseases Do not have fatty liver Do not take other drugs that affect the level of liver enzymes

Exclusion criteria

Exclusion criteria: Change in the definitive diagnosis of epilepsy Existence of underlying diseases that affect the metabolism of vitamin D and calcium Taking medication or drugs that affect calcium and vitamin D metabolism Dissatisfaction of parents Failure to follow instructions and perform tests Changing the treatment protocol Drug allergy Physical disorder that hinders the patient's activity. History of fracture Vitamin D deficiency Low calcium levels Acute and chronic liver diseases Taking other drugs with hepatic metabolism

Design outcomes

Primary

Measure	Time frame
Liver enzyme levels and vitamin D levels. Timepoint: In two rounds and with an interval of 3 months from the start of taking the drug. Method of measurement: Blood test.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSamaneh Safari

Shahre-kord University of Medical Sciences

st-safari.s@skums.ac.ir+98 38 3222 0016

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026