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Active, Not Recruiting

NCT Number: NCT04694235

Egg Intervention During Pregnancy in Indonesia

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Weight Gain Amino Acid Deficiency Anemia Anemia, Hypochromic Anemia, Iron Deficiency Anemia, Iron-Deficiency Avitaminosis B12 Deficiency Vitamin Bacterial Infections Bacterial Infections and Mycoses Birth Length Birth Weight Body Weight Body Weight Changes Child Development Deficiency Diseases Digestive System Diseases Dysentery Dysentery, Bacillary E. Coli Infection Enterobacteriaceae Infections Escherichia coli Infections Fatty Acid Deficiency Folate Deficiency Folic Acid Deficiency Gastroenteritis Gastrointestinal Diseases Gram-Negative Bacterial Infections Hematologic Diseases Hemic and Lymphatic Diseases Infections Intestinal Diseases Iron Deficiencies Iron Metabolism Disorders Malnutrition Metabolic Diseases Mineral Deficiency Nutrition Disorders Nutritional and Metabolic Diseases Parasite Infestation Parasitic Diseases Pathological Conditions, Signs and Symptoms Protozoan Infections Salmonella Infections Shigella Infection Signs and Symptoms Vitamin A Deficiency Vitamin B 12 Deficiency Vitamin B Deficiency Zinc Deficiency

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Aikmel, Sakra, and Sikur Subdistrict

Mataram, West Nusa Tenggara, Indonesia

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Woman is between 16 and 20 weeks of pregnancy based on the date of the first day of her last menstrual period.
  • She is 18-40 years of age.
  • She is planning to remain in the study area over the next 30 months.
  • She is of Sasak ethnicity

Exclusion criteria

  • She is expecting multiple births.
  • She has a known egg allergy.

Treatment and study plan

Egg intervention

Dietary Supplement

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.

Primary outcomes

  1. Prevalence of stunting

    Time frame: birth until 24 months after delivery

    Z-score of LAZ <-2 SD based on WHO 2006

  2. Proportion of children 10-14 months with impaired fine and gross motor skills

    Time frame: 10-14 months of age

    Oxford Neurodevelopment Assessment (OX-NDA) is used to assess fine and gross motor skills among children aged 10 to 14 months

  3. Proportion of children 10-14 months with impaired expressive and receptive language

    Time frame: 10-14 months of age

    Oxford Neurodevelopment Assessment (OX-NDA) is used to assess expressive and receptive language among children aged 10 to 14 months

  4. Proportion of children 10-14 months with impaired behavior

    Time frame: 10-14 months of age

    Oxford Neurodevelopment Assessment (OX-NDA) is used to assess behavior among children aged 10 to 14 months

  5. Proportion of children 10-14 months with impaired executive function

    Time frame: 10-14 months of age

    Oxford Neurodevelopment Assessment (OX-NDA) is used to assess executive function among children aged 10 to 14 months

  6. Proportion of children 10-14 months with impaired empathy

    Time frame: 10-14 months of age

    Oxford Neurodevelopment Assessment (OX-NDA) is used to assess empathy among children aged 10 to 14 months

  7. Proportion of children 10-14 months with impaired problem solving

    Time frame: 10-14 months of age

    Oxford Neurodevelopment Assessment (OX-NDA) is used to assess problem solving among children aged 10 to 14 months

  8. Proportion of children 10-14 months with impaired attention

    Time frame: 10-14 months of age

    Oxford Neurodevelopment Assessment (OX-NDA) is used to assess attention among children aged 10 to 14 months

  9. Proportion of children 10-14 months with impaired social-emotional reactivity

    Time frame: 10-14 months of age

    Oxford Neurodevelopment Assessment (OX-NDA) is used to assess social-emotional reactivity among children aged 10 to 14 months

  10. Proportion of children 20-24 months with impaired motor development

    Time frame: 20-24 months of age

    INTERGROWTH Neurodevelopment Assessment (INTER-NDA) is used to assess motor development among children aged 20 to 24 months

  11. Proportion of children 20-24 months with impaired cognition

    Time frame: 20-24 months of age

    INTERGROWTH Neurodevelopment Assessment (INTER-NDA) is used to assess cognition among children aged 20 to 24 months

  12. Proportion of children 20-24 months with impaired language

    Time frame: 20-24 months of age

    INTERGROWTH Neurodevelopment Assessment (INTER-NDA) is used to assess language among children aged 20 to 24 months

  13. Proportion of children 20-24 months with impaired social-emotional development

    Time frame: 20-24 months of age

    INTERGROWTH Neurodevelopment Assessment (INTER-NDA) is used to assess social-emotional development among children aged 20 to 24 months

  14. Scores of CDI vocabulary comprehension scale in children 10-12 months

    Time frame: 10-12 months of age

    MacArthur-Bates Communicative Development Inventories (CDI) is used to assess vocabulary comprehension scale among children aged 10 to 12 months

  15. Scores of CDI vocabulary production scale in children 10-12 months

    Time frame: 10-12 months of age

    MacArthur-Bates Communicative Development Inventories (CDI) is used to assess vocabulary production among children aged 10 to 12 months

  16. Epigenetic state of genes associated with stunting

    Time frame: parents: 72 h after delivery; baby: 72 h after delivery, 24 month

    Genome-wide analysis of epigenetic states using the Illumina Infinium Methylation EPIC 850k Bead Chip (EPIC array) will be performed for selected samples from the core cohort. The outcomes will be the epigenetic state of a large number of genes which are associated with child stunting.

  17. Epigenetic markers of birth anthropometry, adult stature, metabolic state, and cognitive ability

    Time frame: parents: 72 h after delivery; baby: 72 h after delivery, 24 month

    All samples (newborn, children 24 mo, parents) will be analyzed using Next Generation Bisulphite Amplicon Sequencing (BSAS) from Illumina MiSeq platform in targeted regions of the genome. The outcomes will be profiles of specific epigenetic markers of birth anthropometry, adult stature, metabolic state, and cognitive ability.

Secondary outcomes

  1. Weight gain during pregnancy

    Time frame: 2nd trimester (16-20 weeks gestation) and 3rd trimester (28-32 weeks gestation) of pregnancy

    All measurements will be taken to the nearest 0.1 kg using standard procedures with SECA weighing machine.

  2. Birth weight

    Time frame: 24 hours after birth

    All measurements will be taken to the nearest 0.1 kg using standard procedures with SECA weighing machine.

  3. Birth length

    Time frame: 24 hours after birth

    All measurements will be taken to the nearest milimeter using standard procedures with SECA stadiometer/infantometer.

  4. Hemoglobin concentration

    Time frame: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery

    Nutritional status measured by biochemical assessment to the mothers and children. Both the pregnant mothers and children will be measured for their hemoglobin.

  5. Serum ferritin concentration

    Time frame: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery

    Nutritional status measured by biochemical assessment to the mothers and children. Both the pregnant mothers and children will be measured for their serum ferritin

  6. Serum transferrin receptor concentration

    Time frame: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery

    Nutritional status measured by biochemical assessment to the mothers and children. Both the pregnant mothers and children will be measured for their serum transferrin receptor

  7. Serum zinc concentration

    Time frame: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery

    Nutritional status measured by biochemical assessment to the mothers and children. Both the pregnant mothers and children will be measured for their serum zinc

  8. Serum retinol concentration

    Time frame: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery

    Nutritional status measured by biochemical assessment to the mothers and children. Both the pregnant mothers and children will be measured for their serum retinol

  9. RBC folate concentration

    Time frame: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery

    Nutritional status measured by biochemical assessment to the mothers and children. Both the pregnant mothers and children will be measured for their RBC folate

  10. Serum vitamin B12 concentration

    Time frame: Mothers: second and third trimester of pregnancy

    Nutritional status measured by biochemical assessment to the mothers for their serum vitamin B12

  11. RBC fatty acids concentration

    Time frame: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery

    Nutritional status measured by biochemical assessment to the mothers and children. Both the pregnant mothers and children will be measured for their RBC fatty acids

  12. Serum essential amino acids concentration

    Time frame: Mothers: second and third trimester of pregnancy

    Nutritional status measured by biochemical assessment to the mothers for their serum essential amino acids

  13. Serum methylmalonic acid concentration

    Time frame: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery

    Nutritional status measured by biochemical assessment to the mothers and children. Both the pregnant mothers and children will be measured for their serum methylmalonic acid

  14. Serum choline concentration

    Time frame: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery

    Nutritional status measured by biochemical assessment to the mothers and children. Both the pregnant mothers and children will be measured for their serum choline

  15. Serum betaine concentration

    Time frame: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery

    Nutritional status measured by biochemical assessment to the mothers and children. Both the pregnant mothers and children will be measured for their serum betaine

  16. Serum vitamin B2 concentration

    Time frame: Mothers: second and third trimester of pregnancy

    Nutritional status measured by biochemical assessment to the mothers for their serum vitamin B2

  17. Serum vitamin B6 concentration

    Time frame: Mothers: second and third trimester of pregnancy

    Nutritional status measured by biochemical assessment to the mothers for their serum vitamin B6

  18. Serum vitamin D concentration

    Time frame: Mothers: second and third trimester of pregnancy

    Nutritional status measured by biochemical assessment to the mothers for their serum vitamin D

  19. Serum CRP concentration

    Time frame: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery

    Subclinical inflammation will be measured by serum CRP in pregnant mothers and children

  20. Serum AGP concentration

    Time frame: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery

    Subclinical inflammation will be measured by serum AGP in pregnant mothers and children

  21. Serum RBP concentration

    Time frame: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery

    Nutritional status measured by biochemical assessment to the mothers and children. Both the pregnant mothers and children will be measured for their serum RBP

  22. Serum hepcidine concentration

    Time frame: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery

    Nutritional status measured by biochemical assessment to the mothers and children. Both the pregnant mothers and children will be measured for their serum hepcidine

  23. Serum homocysteine concentration

    Time frame: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery

    Nutritional status measured by biochemical assessment to the mothers and children. Both the pregnant mothers and children will be measured for their serum homocysteine

  24. Serum HbA1C concentration

    Time frame: Mothers: second and third trimester of pregnancy

    Gestational diabetes status will be assesed to the mothers for their serum HbA1C

  25. Fecal myeloperoxidase (MPO)

    Time frame: baby: 1, 6, 24 months of age

    Gut inflammation from fecal will be measured by faecal myeloperoxidase (MPO) using ELISA

  26. Fecal α1-antitrypsin (AAT)

    Time frame: baby: 1, 6, 24 months of age

    Gut inflammation from fecal will be measured by fecal α1-antitrypsin (AAT) using ELISA

  27. Soil-transmitted helminths infection

    Time frame: mothers: 3rd trimester (28-32 gestational weeks) of pregnancy; baby: 1, 6, 24 months of age

    Fecal parasites from fecal will be assesed by Kato Katz and confirmed by qPCR

  28. Bacteria infection

    Time frame: baby: 1, 6, 24 months of age

    Type of bacteria (Salmonella, Shigella) from fecal will be assesed by culture method

  29. Gut microbiota

    Time frame: baby: 1, 6, 24 months of age

    Gut microbiota species (EPEC, ETEC, EHEC, EIEC) from fecal will be assesed using qPCR

  30. Gut microbiome

    Time frame: baby: 1, 6, 24 months of age

    Faecal microbiome would be analyzed using 16S RNA sequencing of the V4 region on the Illumina MiSeq and BSAS.

  31. Intestinal fatty acid binding protein

    Time frame: baby: 6 months of age

    Intestinal fatty acid binding protein from serum will be measured using ELISA

Sponsors and collaborators

Lead sponsor

SEAMEO Regional Centre for Food and Nutrition

Other

Collaborators

  • Birkbeck, University of London
  • Cheikh Anta Diop University, Senegal
  • Digital Green Foundation
  • International Centre for Research in Agroforestry
  • International Initiative for Impact Evaluation
  • Liverpool School of Tropical Medicine
  • London School of Hygiene and Tropical Medicine
  • National Institute of Nutrition, India
  • Royal Veterinary College
  • SOAS, University of London
  • Science Made Simple
  • The International Livestock Research Institute (ILRI)
  • University College, London
  • University of Aberdeen
  • University of Brighton
  • University of Sheffield

Registry information

Official study title

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

Acronym: PRECODE

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jan 5, 2021
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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