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Clinical Trial 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


Clinical Trial 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). ;


Study Design


Related Conditions & MeSH terms

  • Amino Acid Deficiency
  • Anemia, Iron Deficiency
  • Anemia, Iron-Deficiency
  • B12 Deficiency Vitamin
  • Birth Length
  • Birth Weight
  • Body Weight
  • Child Development
  • Communicable Diseases
  • Dysentery, Bacillary
  • E. Coli Infection
  • Escherichia coli Infections
  • Fatty Acid Deficiency
  • Folate Deficiency
  • Folic Acid Deficiency
  • Infection
  • Mineral Deficiency
  • Night Blindness
  • Parasite Infestation
  • Protozoan Infections
  • Salmonella Infections
  • Shigella Infection
  • Vitamin A Deficiency
  • Vitamin B 12 Deficiency
  • Weight Gain
  • Zinc Deficiency

NCT number NCT04694235
Study type Interventional
Source SEAMEO Regional Centre for Food and Nutrition
Contact Arienta RP Sudibya, M.Sc
Phone +628118113811
Email arientasudibya@seameo-recfon.org
Status Recruiting
Phase N/A
Start date February 12, 2021
Completion date March 2024

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