Amino Acid Deficiency, Anemia, Iron Deficiency, B12 Deficiency Vitamin, Birth Length, Birth Weight, Child Development, E. Coli Infection, Fatty Acid Deficiency, Folate Deficiency, Mineral Deficiency, Parasite Infestation, Protozoan Infections, Salmonella Infections, Shigella Infection, Vitamin A Deficiency, Weight Gain, Zinc Deficiency
Conditions
Keywords
Egg, Pregnancy, Indonesia, Epigenetic, Growth, Child development
Brief 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).
Interventions
DIETARY_SUPPLEMENTEgg 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.
Sponsors
London School of Hygiene and Tropical Medicine
University of Aberdeen
University of Brighton
University College, London
Royal Veterinary College
Birkbeck, University of London
The International Livestock Research Institute (ILRI)
Cheikh Anta Diop University, Senegal
National Institute of Nutrition, India
International Centre for Research in Agroforestry
Science Made Simple
Liverpool School of Tropical Medicine
International Initiative for Impact Evaluation
Digital Green Foundation
SOAS, University of London
University of Sheffield
SEAMEO Regional Centre for Food and Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of stunting | birth until 24 months after delivery | Z-score of LAZ \<-2 SD based on WHO 2006 |
| Proportion of children 10-14 months with impaired fine and gross motor skills | 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 |
| Proportion of children 10-14 months with impaired expressive and receptive language | 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 |
| Proportion of children 10-14 months with impaired behavior | 10-14 months of age | Oxford Neurodevelopment Assessment (OX-NDA) is used to assess behavior among children aged 10 to 14 months |
| Proportion of children 10-14 months with impaired executive function | 10-14 months of age | Oxford Neurodevelopment Assessment (OX-NDA) is used to assess executive function among children aged 10 to 14 months |
| Proportion of children 10-14 months with impaired empathy | 10-14 months of age | Oxford Neurodevelopment Assessment (OX-NDA) is used to assess empathy among children aged 10 to 14 months |
| Proportion of children 10-14 months with impaired problem solving | 10-14 months of age | Oxford Neurodevelopment Assessment (OX-NDA) is used to assess problem solving among children aged 10 to 14 months |
| Proportion of children 10-14 months with impaired attention | 10-14 months of age | Oxford Neurodevelopment Assessment (OX-NDA) is used to assess attention among children aged 10 to 14 months |
| Proportion of children 10-14 months with impaired social-emotional reactivity | 10-14 months of age | Oxford Neurodevelopment Assessment (OX-NDA) is used to assess social-emotional reactivity among children aged 10 to 14 months |
| Proportion of children 20-24 months with impaired motor development | 20-24 months of age | INTERGROWTH Neurodevelopment Assessment (INTER-NDA) is used to assess motor development among children aged 20 to 24 months |
| Proportion of children 20-24 months with impaired cognition | 20-24 months of age | INTERGROWTH Neurodevelopment Assessment (INTER-NDA) is used to assess cognition among children aged 20 to 24 months |
| Proportion of children 20-24 months with impaired language | 20-24 months of age | INTERGROWTH Neurodevelopment Assessment (INTER-NDA) is used to assess language among children aged 20 to 24 months |
| Proportion of children 20-24 months with impaired social-emotional development | 20-24 months of age | INTERGROWTH Neurodevelopment Assessment (INTER-NDA) is used to assess social-emotional development among children aged 20 to 24 months |
| Scores of CDI vocabulary comprehension scale in children 10-12 months | 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 |
| Scores of CDI vocabulary production scale in children 10-12 months | 10-12 months of age | MacArthur-Bates Communicative Development Inventories (CDI) is used to assess vocabulary production among children aged 10 to 12 months |
| Epigenetic state of genes associated with stunting | 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. |
| Epigenetic markers of birth anthropometry, adult stature, metabolic state, and cognitive ability | 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
| Measure | Time frame | Description |
|---|---|---|
| Serum vitamin D concentration | Mothers: second and third trimester of pregnancy | Nutritional status measured by biochemical assessment to the mothers for their serum vitamin D |
| Serum CRP concentration | 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 |
| Serum AGP concentration | 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 |
| Serum RBP concentration | 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 |
| Serum hepcidine concentration | 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 |
| Serum homocysteine concentration | 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 |
| Serum HbA1C concentration | Mothers: second and third trimester of pregnancy | Gestational diabetes status will be assesed to the mothers for their serum HbA1C |
| Fecal myeloperoxidase (MPO) | baby: 1, 6, 24 months of age | Gut inflammation from fecal will be measured by faecal myeloperoxidase (MPO) using ELISA |
| Fecal α1-antitrypsin (AAT) | baby: 1, 6, 24 months of age | Gut inflammation from fecal will be measured by fecal α1-antitrypsin (AAT) using ELISA |
| Soil-transmitted helminths infection | 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 |
| Bacteria infection | baby: 1, 6, 24 months of age | Type of bacteria (Salmonella, Shigella) from fecal will be assesed by culture method |
| Gut microbiota | baby: 1, 6, 24 months of age | Gut microbiota species (EPEC, ETEC, EHEC, EIEC) from fecal will be assesed using qPCR |
| Gut microbiome | 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. |
| Weight gain during pregnancy | 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. |
| Intestinal fatty acid binding protein | baby: 6 months of age | Intestinal fatty acid binding protein from serum will be measured using ELISA |
| Birth weight | 24 hours after birth | All measurements will be taken to the nearest 0.1 kg using standard procedures with SECA weighing machine. |
| Birth length | 24 hours after birth | All measurements will be taken to the nearest milimeter using standard procedures with SECA stadiometer/infantometer. |
| Hemoglobin concentration | 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. |
| Serum ferritin concentration | 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 |
| Serum transferrin receptor concentration | 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 |
| Serum zinc concentration | 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 |
| Serum retinol concentration | 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 |
| RBC folate concentration | 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 |
| Serum vitamin B12 concentration | Mothers: second and third trimester of pregnancy | Nutritional status measured by biochemical assessment to the mothers for their serum vitamin B12 |
| RBC fatty acids concentration | 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 |
| Serum essential amino acids concentration | Mothers: second and third trimester of pregnancy | Nutritional status measured by biochemical assessment to the mothers for their serum essential amino acids |
| Serum methylmalonic acid concentration | 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 |
| Serum choline concentration | 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 |
| Serum betaine concentration | 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 |
| Serum vitamin B2 concentration | Mothers: second and third trimester of pregnancy | Nutritional status measured by biochemical assessment to the mothers for their serum vitamin B2 |
| Serum vitamin B6 concentration | Mothers: second and third trimester of pregnancy | Nutritional status measured by biochemical assessment to the mothers for their serum vitamin B6 |
Countries
Indonesia
Outcome results
None listed