NCT04694235

Egg Intervention During Pregnancy in Indonesia

Effect on Pregnancy Outcomes, Infant Growth and Development of an Egg Intervention During Pregnancy in Indonesia

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 702 (actual)
• Sponsor: SEAMEO Regional Centre for Food and Nutrition · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The study consists of two arms: 1) intervention group using eggs as supplementary food given from 2nd trimester of pregnancy to birth, and 2) observational group of pregnant mothers. it aims to assess the effectiveness of improving dietary quality during pregnancy on the epigenetic and stunting related outcomes (growth and development) in infants, who will be followed up until 24 months old

Detailed description

The study aims to assess the impact of improving dietary quality during pregnancy on the epigenetic and stunting related outcomes in infants. The open-label intervention study would be conducted alongside the observational study in the same study setting by recruitment of additional number (n=153) of pregnant women. Thus, a total of 653 pregnant women would be enrolled in the study; 153 women would be randomized to intervention arm and 500 to the control arm who would form an observational cohort of women and newborns as described above. The intervention group women will be provided one egg three times per week from recruitment (2nd trimester) until term. The control group women will receive standard intervention in the form of Ante Natal Care from village midwives or Public Health Centre (IFA tablet, calcium tablet, nutrition counselling).

Conditions

• Weight Gain
• Anemia, Iron Deficiency
• Birth Weight
• Birth Length
• Child Development
• Zinc Deficiency
• Folate Deficiency
• B12 Deficiency Vitamin
• Amino Acid Deficiency
• Mineral Deficiency
• Vitamin A Deficiency
• Fatty Acid Deficiency
• Parasite Infestation
• E. Coli Infection
• Salmonella Infections
• Shigella Infection
• Protozoan Infections

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Egg intervention	Eggs are boiled until the white and yolk are firm (ca. 8 minutes) to maintain quality and safety and ensure the eggs are safe for consumption.

Timeline

• Start date: 2021-02-12
• Primary completion: 2024-05-01
• Completion: 2024-09-30
• First posted: 2021-01-05
• Last updated: 2024-07-03

Locations

1 site across 1 country: Indonesia