Investigating the effect of supplementation with nano omega-3 in mothers on the control of cow's milk protein allergy

Studying the effect of supplementing with nano-form omega-3 in mothers on controlling cow's milk protein allergy in breastfed children and comparing it with regular omega-3

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20240119060733N2

Enrollment

108

Registered

2024-12-15

Start date

2025-01-20

Completion date

Unknown

Last updated

2025-01-08

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

Conditions

Cow's milk protein allergy. Allergy to milk products

Interventions

Intervention 1: Intervention group: In this group, in addition to a dairy-free diet, mothers receive 2,000 mg of nano-form omega-3 daily in two doses of 1,000 mg for 12 weeks. Intervention 2: Control

Eligibility

Sex/Gender

All

Age

No minimum to 21 Months

Inclusion criteria

Inclusion criteria: The mother has a baby with a cow's milk protein allergy. The baby should be breastfed and not formula fed. The mother is willing to participate in the study.

Exclusion criteria

Exclusion criteria: Presence of coagulation disorders in the mother or baby Presence of metabolic diseases in the newborn

Design outcomes

Primary

Measure	Time frame
Clinical symptoms associated with cow's milk protein allergy. Timepoint: Initially, before entering the study and at the end of the twelfth week of the study. Method of measurement: With the help of a clinical symptom checklist.	—

Secondary

Measure	Time frame
Omega-3 levels in breast milk. Timepoint: At the beginning of the study and at the end of the twelfth week of the study. Method of measurement: Evaluation of the fatty acid profile of breast milk by gas chromatography.;Child's mental development. Timepoint: At the beginning of the study and at the end of the twelfth week of the study. Method of measurement: With the help of the ASQ questionnaire.;Weight and weight percentiles. Timepoint: At the beginning of the study and at the end of the twelfth week of the study. Method of measurement: Weight is measured using a scale and percentiles are calculated according to age.;Newborn height and height percentiles. Timepoint: At the beginning of the study and at the end of the twelfth week of the study. Method of measurement: The baby's height is measured using a standard, non-elastic tape measure.;Head circumference and related percentiles. Timepoint: At the beginning of the study and at the end of the twelfth week of the study. Method of measurement: The baby's head circumference is measured using a standard, non-elastic tape measure. The largest circumference around the head is taken as the head circumference.	—

Measure

Time frame

Omega-3 levels in breast milk. Timepoint: At the beginning of the study and at the end of the twelfth week of the study. Method of measurement: Evaluation of the fatty acid profile of breast milk by gas chromatography.;Child's mental development. Timepoint: At the beginning of the study and at the end of the twelfth week of the study. Method of measurement: With the help of the ASQ questionnaire.;Weight and weight percentiles. Timepoint: At the beginning of the study and at the end of the twelfth week of the study. Method of measurement: Weight is measured using a scale and percentiles are calculated according to age.;Newborn height and height percentiles. Timepoint: At the beginning of the study and at the end of the twelfth week of the study. Method of measurement: The baby's height is measured using a standard, non-elastic tape measure.;Head circumference and related percentiles. Timepoint: At the beginning of the study and at the end of the twelfth week of the study. Method of measurement: The baby's head circumference is measured using a standard, non-elastic tape measure. The largest circumference around the head is taken as the head circumference.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMorteza Ghasemi

Mashhad University of Medical Sciences

ghasemim4012@mums.ac.ir+98 51 3800 2000

Outcome results

None listed

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