Clinical trial NCT04694235: Egg Intervention During Pregnancy in Indonesia
Official title: Effect on Pregnancy Outcomes, Infant Growth and Development of an Egg Intervention During Pregnancy in Indonesia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Weight Gain
Anemia, Iron Deficiency
Birth Weight
Birth Length
Child Development
Zinc Deficiency
Folate Deficiency
B12 Deficiency Vitamin
Amino Acid Deficiency
Mineral Deficiency
Vitamin A Deficiency
Fatty Acid Deficiency
Parasite Infestation
E. Coli Infection
Salmonella Infections
Shigella Infection
Protozoan Infections
Keywords: Egg
Pregnancy
Indonesia
Epigenetic
Growth
Child development
Lead sponsor: SEAMEO Regional Centre for Food and Nutrition
Sponsor class: OTHER
Collaborators: name: London School of Hygiene and Tropical Medicine
name: University of Aberdeen
name: University of Brighton
name: University College, London
name: Royal Veterinary College
name: Birkbeck, University of London
name: The International Livestock Research Institute (ILRI)
name: Cheikh Anta Diop University, Senegal
name: National Institute of Nutrition, India
name: International Centre for Research in Agroforestry
name: Science Made Simple
name: Liverpool School of Tropical Medicine
name: International Initiative for Impact Evaluation
name: Digital Green Foundation
name: SOAS, University of London
name: University of Sheffield
First posted: 2021-01-05
Enrollment: 702
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence of stunting
timeFrame: birth until 24 months after delivery
measure: Proportion of children 10-14 months with impaired fine and gross motor skills
timeFrame: 10-14 months of age
measure: Proportion of children 10-14 months with impaired expressive and receptive language
timeFrame: 10-14 months of age
measure: Proportion of children 10-14 months with impaired behavior
timeFrame: 10-14 months of age
measure: Proportion of children 10-14 months with impaired executive function
timeFrame: 10-14 months of age
measure: Proportion of children 10-14 months with impaired empathy
timeFrame: 10-14 months of age
measure: Proportion of children 10-14 months with impaired problem solving
timeFrame: 10-14 months of age
measure: Proportion of children 10-14 months with impaired attention
timeFrame: 10-14 months of age
measure: Proportion of children 10-14 months with impaired social-emotional reactivity
timeFrame: 10-14 months of age
measure: Proportion of children 20-24 months with impaired motor development
timeFrame: 20-24 months of age
measure: Proportion of children 20-24 months with impaired cognition
timeFrame: 20-24 months of age
measure: Proportion of children 20-24 months with impaired language
timeFrame: 20-24 months of age
measure: Proportion of children 20-24 months with impaired social-emotional development
timeFrame: 20-24 months of age
measure: Scores of CDI vocabulary comprehension scale in children 10-12 months
timeFrame: 10-12 months of age
measure: Scores of CDI vocabulary production scale in children 10-12 months
timeFrame: 10-12 months of age
measure: Epigenetic state of genes associated with stunting
timeFrame: parents: 72 h after delivery; baby: 72 h after delivery, 24 month
measure: Epigenetic markers of birth anthropometry, adult stature, metabolic state, and cognitive ability
timeFrame: parents: 72 h after delivery; baby: 72 h after delivery, 24 month
Secondary outcomes:
measure: Weight gain during pregnancy
timeFrame: 2nd trimester (16-20 weeks gestation) and 3rd trimester (28-32 weeks gestation) of pregnancy
measure: Birth weight
timeFrame: 24 hours after birth
measure: Birth length
timeFrame: 24 hours after birth
measure: Hemoglobin concentration
timeFrame: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery
measure: Serum ferritin concentration
timeFrame: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery
measure: Serum transferrin receptor concentration
timeFrame: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery
measure: Serum zinc concentration
timeFrame: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery
measure: Serum retinol concentration
timeFrame: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery
measure: RBC folate concentration
timeFrame: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery
measure: Serum vitamin B12 concentration
timeFrame: Mothers: second and third trimester of pregnancy
measure: RBC fatty acids concentration
timeFrame: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery
measure: Serum essential amino acids concentration
timeFrame: Mothers: second and third trimester of pregnancy
measure: Serum methylmalonic acid concentration
timeFrame: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery
measure: Serum choline concentration
timeFrame: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery
measure: Serum betaine concentration
timeFrame: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery
measure: Serum vitamin B2 concentration
timeFrame: Mothers: second and third trimester of pregnancy
measure: Serum vitamin B6 concentration
timeFrame: Mothers: second and third trimester of pregnancy
measure: Serum vitamin D concentration
timeFrame: Mothers: second and third trimester of pregnancy
measure: Serum CRP concentration
timeFrame: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery
measure: Serum AGP concentration
timeFrame: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery
measure: Serum RBP concentration
timeFrame: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery
measure: Serum hepcidine concentration
timeFrame: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery
measure: Serum homocysteine concentration
timeFrame: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery
measure: Serum HbA1C concentration
timeFrame: Mothers: second and third trimester of pregnancy
measure: Fecal myeloperoxidase (MPO)
timeFrame: baby: 1, 6, 24 months of age
measure: Fecal α1-antitrypsin (AAT)
timeFrame: baby: 1, 6, 24 months of age
measure: Soil-transmitted helminths infection
timeFrame: mothers: 3rd trimester (28-32 gestational weeks) of pregnancy; baby: 1, 6, 24 months of age
measure: Bacteria infection
timeFrame: baby: 1, 6, 24 months of age
measure: Gut microbiota
timeFrame: baby: 1, 6, 24 months of age
measure: Gut microbiome
timeFrame: baby: 1, 6, 24 months of age
measure: Intestinal fatty acid binding protein
timeFrame: baby: 6 months of age
Other outcomes:
Locations:
city: Mataram
country: Indonesia
facility: Aikmel, Sakra, and Sikur Subdistrict
state: West Nusa Tenggara
Study officials:
affiliation: SEAMEO RECFON
name: Umi Fahmida, Dr.
role: PRINCIPAL_INVESTIGATOR
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