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Active, not recruitingNCT07863206OMEGA-MOMUpdated Oct 7, 2026

Omega-3 Egg Intervention and Nutrition Education in Pregnant Women

An interventional study of Omega-3 Enriched Eggs and nutrition education in Maternal and Neonatal Outcomes, Pregnancy and Malnutrition Pregnancy, sponsored by Institut Pertanian Bogor. Active, not recruiting at 1 site in Indonesia. Open to female participants aged 20 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-10-07.

Sponsored by Institut Pertanian Bogor · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled May 2026, registered Sep 2026).
Updated Oct 7, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
20 Years to 35 Years
Sex
Female
01

Study summary

The goal of this clinical trial is to evaluate the effect of omega-3 enriched egg supplementation combined with nutrition education in pregnant women with Chronic Energy Deficiency (CED).

The main questions it aims to answer are:

  1. Does omega-3 egg supplementation combined with nutrition education improve maternal nutritional status (nutrient intake, anthropometry, serum DHA, EPA, IL-6, serum albumin, ferritin, knowledge, and Health Belief Model constructs) in pregnant women with CED compared to nutrition education alone?
  2. Does this combined intervention improve pregnancy and neonatal outcomes (gestational age, preterm birth, postpartum hemorrhage, newborn anthropometry, and breast milk fatty acid profile) compared to nutrition education alone?

Researchers will compare the intervention group (receiving omega-3 enriched eggs and nutrition education) to a control group (receiving nutrition education only) to evaluate these effects.

Participants will:

  1. Attend structured nutrition education sessions (both groups)
  2. Consume daily omega-3 enriched eggs during the intervention period (intervention group only)Undergo baseline and follow-up assessments including blood sampling (DHA, EPA, IL-6, albumin, ferritin), anthropometric measurements, and dietary questionnaires
  3. Provide post-delivery and neonatal data, as well as breast milk samples after delivery for fatty acid profiling
02

Conditions studied

  • Maternal and Neonatal Outcomes
  • Pregnancy
  • Malnutrition Pregnancy

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Keywords

  • Omega-3 Fatty Acids
  • Nutrition Education
  • Fortified Eggs
  • Nutritional Status
  • Pregnancy Outcomes
03

In context

Malnutrition

1,277 studies on the registry are indexed under Malnutrition; 230 are open to participants now.

This study's enrollment of 42 is below the median of 118 across 843 interventional studies indexed under Malnutrition.

Browse Malnutrition studies →

Lead sponsor

Institut Pertanian Bogor is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Gestational age of 20-24 weeks (based on last menstrual period [LMP] or ultrasound).
  • Pregnant women with Chronic Energy Deficiency (CED), defined as Mid-Upper Arm Circumference (MUAC) \< 23.5 cm.
  • Aged 20-35 years.
  • No known egg allergy.
  • Egg consumption frequency of 0-1 time per day.
  • Receiving Multiple Micronutrient Supplements (MMS).

Exclusion criteria

Exclusion Criteria:

  • Presence of chronic diseases or pregnancy complications (e.g., preeclampsia, gestational diabetes).
  • Gravidity ≥ 4 (number of pregnancies ≥ 4).
  • History of preterm delivery.
  • Multiple pregnancy (e.g., twin pregnancy).
  • Interpregnancy interval \< 2 years.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
42 participants (actual)

Study arms

  • Experimental
    Omega-3 Egg + Nutrition Education

    Participants in this group receive daily omega-3 enriched eggs combined with structured nutrition education sessions.

    Dietary Supplement: Omega-3 Enriched Eggs · Behavioral: nutrition education

  • Active comparator
    Nutrition Education

    Participants in this group receive standard nutrition education only, without omega-3 egg supplementation.

    Behavioral: nutrition education

Interventions

  • Dietary supplementOmega-3 Enriched Eggs

    Participants will be provided with 2 omega-3 enriched eggs per day to consume daily throughout the study intervention period.

  • Behavioralnutrition education

    Participants will attend structured nutrition education sessions focusing on the importance, sources, and benefits of omega-3 fatty acids during pregnancy for maternal and fetal health.

06

What researchers measure

Primary outcomes

  1. Maternal Serum DHA Level (ug/mL)

    Evaluated via maternal blood serum analysis to measure changes in docosahexaenoic acid (DHA) concentrations before and after intervention, using Gas Chromatography (GC).

    Time frame: Baseline (Day 0) and 10 weeks post-intervention

  2. Newborn Birth Weight (gram)

    Weight of the newborn measured using a calibrated digital infant scale within 24 hours of delivery.

    Time frame: At delivery (within 24 hours post-birth)

  3. Maternal serum EPA level (ug/mL)

    Changes of maternal serum EPA level before and after intervention, using Gas Chromatography (GC).

    Time frame: Baseline (Day 0) and 10 weeks post-intervention

  4. Newborn Birth Length (cm)

    Length of the newborn measured from the top of the head to the heel using a standardized infantometer within 24 hours of delivery.

    Time frame: At delivery (within 24 hours post-birth)

  5. Newborn Head Circumference (cm)

    Maximum occipitofrontal circumference of the newborn measured using a non-stretchable measuring tape within 24 hours of delivery.

    Time frame: at delivery (within 24 hours post-birth)

Secondary outcomes

  1. Maternal Serum Albumin Level (g/dL)

    Concentration of albumin in maternal blood serum measured post-intervention or at delivery to evaluate maternal protein nutritional status.

    Time frame: Baseline (Day 0) and 10 weeks post-intervention

  2. Gestational Age at Delivery

    Recorded in completed weeks and days at the time of delivery, determined by early ultrasound examination or last menstrual period (LMP). Unit of Measure: Weeks

    Time frame: At delivery

  3. Incidence of Preterm Delivery

    Proportion of live births occurring prior to 37 completed weeks of gestation.

    Time frame: At delivery

  4. Breast Milk Docosahexaenoic Acid (DHA) Level

    Concentration of DHA in breast milk samples collected post-partum, expressed as a percentage of total fatty acids, analyzed using gas chromatography.

    Time frame: At 7 to 14 day postpartum

  5. Maternal Serum Ferritin Levels (ng/mL)

    Concentration of ferritin in maternal blood serum measured post-intervention or at delivery to evaluate maternal iron storage levels.

    Time frame: Baseline (Day 0) and 10 weeks post-intervention

07

Study locations

1 site
  • Parung Panjang Public Health Center
    Bogor, West Java 16360, Indonesia
08

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared to protect participant confidentiality and privacy, as explicit consent for public data sharing was not obtained during the informed consent process.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2026 (actual). Primary completion is estimated for Nov 2026, 6 months after the start.

Of 392 non-industry interventional studies with no phase under Malnutrition, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 37. This study's planned 6 months is below that.

Counting every sponsor, half of 418 studies reached it within 22 months; a quarter within 11 and three quarters within 37.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 24, 2026
First posted
Oct 7, 2026
StartActual
May 13, 2026
Primary completionEst.
Nov 26, 2026
CompletionEst.
Dec 30, 2026
Last update
Oct 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 7, 2026
Show all 1 update
  1. Oct 7, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07863206
Lead sponsor
Institut Pertanian Bogor
Responsible party
Harna Harna (Principal Investigator, Institut Pertanian Bogor) — Principal investigator
First posted
Oct 7, 2026
Start date
May 13, 2026
Primary completion
Nov 26, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Oct 7, 2026

Study contacts

Harna Harna
principal investigator · Institut Pertanian Bogor

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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