Egg Intervention During Pregnancy in Indonesia
- Conditions
- Birth LengthWeight GainFolate DeficiencyFatty Acid DeficiencyParasite InfestationE. Coli InfectionMineral DeficiencyAnemia, Iron DeficiencyBirth WeightChild Development
- Interventions
- Dietary Supplement: Egg intervention
- Registration Number
- NCT04694235
- Lead Sponsor
- SEAMEO Regional Centre for Food and Nutrition
- 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).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 702
- 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
- She is expecting multiple births.
- She has a known egg allergy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group Egg intervention The intervention group women (n=153) will be provided one egg three times per week from recruitment (2nd trimester) until term along with the standard Ante Natal Care.
- Primary Outcome Measures
Name Time Method 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 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 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 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
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 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 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 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 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 behavior 10-14 months of age Oxford Neurodevelopment Assessment (OX-NDA) is used to assess behavior among children aged 10 to 14 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
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
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 Outcome Measures
Name Time Method Birth length 24 hours after birth All measurements will be taken to the nearest milimeter using standard procedures with SECA stadiometer/infantometer.
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 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 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
Gut microbiota baby: 1, 6, 24 months of age Gut microbiota species (EPEC, ETEC, EHEC, EIEC) from fecal will be assesed using qPCR
Intestinal fatty acid binding protein baby: 6 months of age Intestinal fatty acid binding protein from serum will be measured using ELISA
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 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
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
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.
Birth weight 24 hours after birth All measurements will be taken to the nearest 0.1 kg using standard procedures with SECA weighing machine.
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 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 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 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 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 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 α1-antitrypsin (AAT) baby: 1, 6, 24 months of age Gut inflammation from fecal will be measured by fecal α1-antitrypsin (AAT) using ELISA
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
Bacteria infection baby: 1, 6, 24 months of age Type of bacteria (Salmonella, Shigella) from fecal will be assesed by culture method
Fecal myeloperoxidase (MPO) baby: 1, 6, 24 months of age Gut inflammation from fecal will be measured by faecal myeloperoxidase (MPO) 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
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.
Trial Locations
- Locations (1)
Aikmel, Sakra, and Sikur Subdistrict
🇮🇩Mataram, West Nusa Tenggara, Indonesia