An interventional study of Egg intervention in Weight Gain, Anemia, Iron Deficiency and Birth Weight, sponsored by SEAMEO Regional Centre for Food and Nutrition. Active, not recruiting at 1 site in Indonesia. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-03.
Sponsored by SEAMEO Regional Centre for Food and Nutrition · Not applicable, Interventional, and Prevention
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
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).
Exclusion Criteria:
In the observational cohort, pregnant mothers in the 2nd trimester (n=500) will be recruited and they will be followed up until their children are 24 months old. The control group women will receive standard intervention in the form of Ante Natal Care from village midwives (Polindes) or Puskesmas (IFA tablet, calcium tablet, nutrition counselling).
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.
Dietary Supplement: Egg 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.
Prevalence of stunting
Z-score of LAZ \<-2 SD based on WHO 2006
Time frame: birth until 24 months after delivery
Proportion of children 10-14 months with impaired fine and gross motor skills
Oxford Neurodevelopment Assessment (OX-NDA) is used to assess fine and gross motor skills among children aged 10 to 14 months
Time frame: 10-14 months of age
Proportion of children 10-14 months with impaired expressive and receptive language
Oxford Neurodevelopment Assessment (OX-NDA) is used to assess expressive and receptive language among children aged 10 to 14 months
Time frame: 10-14 months of age
Proportion of children 10-14 months with impaired behavior
Oxford Neurodevelopment Assessment (OX-NDA) is used to assess behavior among children aged 10 to 14 months
Time frame: 10-14 months of age
Proportion of children 10-14 months with impaired executive function
Oxford Neurodevelopment Assessment (OX-NDA) is used to assess executive function among children aged 10 to 14 months
Time frame: 10-14 months of age
Proportion of children 10-14 months with impaired empathy
Oxford Neurodevelopment Assessment (OX-NDA) is used to assess empathy among children aged 10 to 14 months
Time frame: 10-14 months of age
Proportion of children 10-14 months with impaired problem solving
Oxford Neurodevelopment Assessment (OX-NDA) is used to assess problem solving among children aged 10 to 14 months
Time frame: 10-14 months of age
Proportion of children 10-14 months with impaired attention
Oxford Neurodevelopment Assessment (OX-NDA) is used to assess attention among children aged 10 to 14 months
Time frame: 10-14 months of age
Proportion of children 10-14 months with impaired social-emotional reactivity
Oxford Neurodevelopment Assessment (OX-NDA) is used to assess social-emotional reactivity among children aged 10 to 14 months
Time frame: 10-14 months of age
Proportion of children 20-24 months with impaired motor development
INTERGROWTH Neurodevelopment Assessment (INTER-NDA) is used to assess motor development among children aged 20 to 24 months
Time frame: 20-24 months of age
Proportion of children 20-24 months with impaired cognition
INTERGROWTH Neurodevelopment Assessment (INTER-NDA) is used to assess cognition among children aged 20 to 24 months
Time frame: 20-24 months of age
Proportion of children 20-24 months with impaired language
INTERGROWTH Neurodevelopment Assessment (INTER-NDA) is used to assess language among children aged 20 to 24 months
Time frame: 20-24 months of age
Proportion of children 20-24 months with impaired social-emotional development
INTERGROWTH Neurodevelopment Assessment (INTER-NDA) is used to assess social-emotional development among children aged 20 to 24 months
Time frame: 20-24 months of age
Scores of CDI vocabulary comprehension scale in children 10-12 months
MacArthur-Bates Communicative Development Inventories (CDI) is used to assess vocabulary comprehension scale among children aged 10 to 12 months
Time frame: 10-12 months of age
Scores of CDI vocabulary production scale in children 10-12 months
MacArthur-Bates Communicative Development Inventories (CDI) is used to assess vocabulary production among children aged 10 to 12 months
Time frame: 10-12 months of age
Epigenetic state of genes associated with stunting
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.
Time frame: parents: 72 h after delivery; baby: 72 h after delivery, 24 month
Epigenetic markers of birth anthropometry, adult stature, metabolic state, and cognitive ability
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.
Time frame: parents: 72 h after delivery; baby: 72 h after delivery, 24 month
Weight gain during pregnancy
All measurements will be taken to the nearest 0.1 kg using standard procedures with SECA weighing machine.
Time frame: 2nd trimester (16-20 weeks gestation) and 3rd trimester (28-32 weeks gestation) of pregnancy
Birth weight
All measurements will be taken to the nearest 0.1 kg using standard procedures with SECA weighing machine.
Time frame: 24 hours after birth
Birth length
All measurements will be taken to the nearest milimeter using standard procedures with SECA stadiometer/infantometer.
Time frame: 24 hours after birth
Hemoglobin concentration
Nutritional status measured by biochemical assessment to the mothers and children. Both the pregnant mothers and children will be measured for their hemoglobin.
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
Serum ferritin concentration
Nutritional status measured by biochemical assessment to the mothers and children. Both the pregnant mothers and children will be measured for their serum ferritin
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
Serum transferrin receptor concentration
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
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
Serum zinc concentration
Nutritional status measured by biochemical assessment to the mothers and children. Both the pregnant mothers and children will be measured for their serum zinc
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
Serum retinol concentration
Nutritional status measured by biochemical assessment to the mothers and children. Both the pregnant mothers and children will be measured for their serum retinol
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
RBC folate concentration
Nutritional status measured by biochemical assessment to the mothers and children. Both the pregnant mothers and children will be measured for their RBC folate
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
Serum vitamin B12 concentration
Nutritional status measured by biochemical assessment to the mothers for their serum vitamin B12
Time frame: Mothers: second and third trimester of pregnancy
RBC fatty acids concentration
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
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
Serum essential amino acids concentration
Nutritional status measured by biochemical assessment to the mothers for their serum essential amino acids
Time frame: Mothers: second and third trimester of pregnancy
Serum methylmalonic acid concentration
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
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
Serum choline concentration
Nutritional status measured by biochemical assessment to the mothers and children. Both the pregnant mothers and children will be measured for their serum choline
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
Serum betaine concentration
Nutritional status measured by biochemical assessment to the mothers and children. Both the pregnant mothers and children will be measured for their serum betaine
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
Serum vitamin B2 concentration
Nutritional status measured by biochemical assessment to the mothers for their serum vitamin B2
Time frame: Mothers: second and third trimester of pregnancy
Serum vitamin B6 concentration
Nutritional status measured by biochemical assessment to the mothers for their serum vitamin B6
Time frame: Mothers: second and third trimester of pregnancy
Serum vitamin D concentration
Nutritional status measured by biochemical assessment to the mothers for their serum vitamin D
Time frame: Mothers: second and third trimester of pregnancy
Serum CRP concentration
Subclinical inflammation will be measured by serum CRP in pregnant mothers and children
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
Serum AGP concentration
Subclinical inflammation will be measured by serum AGP in pregnant mothers and children
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
Serum RBP concentration
Nutritional status measured by biochemical assessment to the mothers and children. Both the pregnant mothers and children will be measured for their serum RBP
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
Serum hepcidine concentration
Nutritional status measured by biochemical assessment to the mothers and children. Both the pregnant mothers and children will be measured for their serum hepcidine
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
Serum homocysteine concentration
Nutritional status measured by biochemical assessment to the mothers and children. Both the pregnant mothers and children will be measured for their serum homocysteine
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
Serum HbA1C concentration
Gestational diabetes status will be assesed to the mothers for their serum HbA1C
Time frame: Mothers: second and third trimester of pregnancy
Fecal myeloperoxidase (MPO)
Gut inflammation from fecal will be measured by faecal myeloperoxidase (MPO) using ELISA
Time frame: baby: 1, 6, 24 months of age
Fecal α1-antitrypsin (AAT)
Gut inflammation from fecal will be measured by fecal α1-antitrypsin (AAT) using ELISA
Time frame: baby: 1, 6, 24 months of age
Soil-transmitted helminths infection
Fecal parasites from fecal will be assesed by Kato Katz and confirmed by qPCR
Time frame: mothers: 3rd trimester (28-32 gestational weeks) of pregnancy; baby: 1, 6, 24 months of age
Bacteria infection
Type of bacteria (Salmonella, Shigella) from fecal will be assesed by culture method
Time frame: baby: 1, 6, 24 months of age
Gut microbiota
Gut microbiota species (EPEC, ETEC, EHEC, EIEC) from fecal will be assesed using qPCR
Time frame: baby: 1, 6, 24 months of age
Gut microbiome
Faecal microbiome would be analyzed using 16S RNA sequencing of the V4 region on the Illumina MiSeq and BSAS.
Time frame: baby: 1, 6, 24 months of age
Intestinal fatty acid binding protein
Intestinal fatty acid binding protein from serum will be measured using ELISA
Time frame: baby: 6 months of age
Plan to share: No
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SEAMEO Regional Centre for Food and Nutrition