Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Anemia, Iron Deficiency
  • Amino Acid Deficiency
  • B12 Deficiency Vitamin
  • Birth Length
  • Birth Weight
  • Child Development
  • E Coli Infection
  • Fatty Acid Deficiency
  • Shigella Infection
  • Protozoan Infections
  • Folate Deficiency
  • Weight Gain
  • Mineral Deficiency
  • Salmonella Infections
  • Vitamin A Deficiency
  • Zinc Deficiency
  • Parasite Infestation
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: A total of 653 pregnant women will be recruited from 40 villages in three sub-districts. Pregnant women will be randomly allocated into the intervention or control groups. Pregnant women in the intervention group will receive boiled eggs three times per week from 2nd trimester (16-20 weeks) until delivery.Masking: None (Open Label)Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 40 years
Gender
Only males

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) o...

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).

Tracking Information

NCT #
NCT04694235
Collaborators
  • London School of Hygiene and Tropical Medicine
  • University of Aberdeen
  • University of Brighton
  • University College, London
  • Royal Veterinary College
  • Birkbeck, University of London
  • University of Sheffield
  • The International Livestock Research Institute (ILRI)
  • Liverpool School of Tropical Medicine
  • Cheikh Anta Diop University, Senegal
  • National Institute of Nutrition, India
  • International Initiative for Impact Evaluation
  • International Centre for Research in Agroforestry
  • Science Made Simple
  • Digital Green Foundation
  • SOAS, University of London
Investigators
Principal Investigator: Umi Fahmida, Dr. SEAMEO RECFON