Double-Blind Cluster Randomized Controlled Trial of Chicken Liver and Eggshell Crackers in Mothers During Pregnancy and Lactation in a Disadvantaged Setting in Indonesia
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 324
- Locations
- 1
- Primary Endpoint
- Birth length
Study Overview
Brief Summary
Our earlier research has highlighted a high prevalence of anaemia, micronutrient deficiencies, and impaired infant growth among lactating women and infants in Sumedang district, West Java, Indonesia that were associated with large deficits in their micronutrient intakes. In response to these disturbing findings we have developed the micronutrient- enriched crackers (MEC) based on powdered eggshells and chicken liver, a readily available and affordable, local animal-source food. We will supply these MEC or a placebo, manufactured locally, weekly to a group of women in Sumedang district from 8-14 weeks gestation to 5 months post-partum in an effort to enrich the micronutrient content of the daily diets of the treatment group so they no longer have any dietary shortfalls in micronutrients. Our overall aim is to determine if MEC consumed daily by mothers for 6 months during pregnancy improves the birth length of their infants, and if daily consumption of MEC is continued daily to 5 months post-partum enhances infant linear growth compared to the placebo.
This study is funded by the UK Wellcome Trust, the grant reference number is 216447/Z/19/Z.
Detailed Description
A double-blind two-phase cluster randomized controlled trial (RCT) will be conducted in West Java, Indonesia to determine whether daily consumption of MEC from 8-14 weeks' gestation to delivery improves birth length compared to placebo (Phase 1) and whether daily consumption of MEC from 8-14 weeks gestation to 5 months post-partum improves attained linear growth of infants at age 5 months and linear growth velocity of infants from birth to age 5 months compared to placebo (Phase 2). A total of 324 pregnant women will be recruited through midwives/public health centre from 28 clusters (villages) in Sumedang district. Clusters will be randomly assigned to receive placebo or micronutrient- enriched crackers (MEC) daily, distributed by cadres from 8-14 weeks gestation to 5 months post-partum. Women who fulfil trial criteria will be invited to participate in the RCT.
Placebo and MEC (based on powdered eggshells and chicken liver) will be manufactured locally according to Standard Operational Procedures (SOPs), so they are identical in size, color, and packaging, with a code known only by the local production manager. The code will not be shared until the primary outcome has been analysed statistically or if requested by the Ethics Committee and/or Data Safety Monitoring Board (DSMB).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to 35 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Pregnant women
- •Gestational age 7-13 weeks at the time of the screening process and be willing to take part in an intervention study at 8-14 weeks gestation
- •Permanent residents who do not plan to move in the next 1 year
Exclusion Criteria
- •Mothers who have chronic diseases such as hypertension (blood pressure > 140/90 mmHg) or under treatment for hypertension, diabetes (non-fasting blood sugar > 200 mg/dL)/ under treatment for diabetes, hypercholesterolemia (blood total cholesterol > 240 mg/dL), hyperuricemia (blood uric acid > 6 mg/dL), have had a history of tuberculosis or under treatment for tuberculosis; or under treatment for other chronic diseases that required a long treatment, such as cancer, heart disease, epilepsy, etc.
- •Have a history of preeclampsia/eclampsia and gestational diabetes in their previous pregnancy
- •Have a risk of chronic energy deficiency (mid-upper arm circumference < 23.5 cm)
- •Have severe anaemia (haemoglobin < 70 g/L or < 7 g/dL)
- •Have a history of allergy to chicken liver and/or eggs
Arms & Interventions
Micronutrient Enriched Crackers (MECs)
Micronutrient Enriched Crackers (MECs) are a deep-fried snack product rich in iron, zinc, calcium, and vitamin A made from chicken liver and chicken eggshell powder.
Consume daily, 75 gram/day, during pregnancy (from 8-14 weeks gestation to delivery) and lactation (from delivery to 5 months post-partum).
Intervention: Micronutrient Enriched Crackers (MECs) (Dietary Supplement)
Placebo
Placebo Crackers are a deep-fried snack product made from the basic cracker ingredients (mainly wheat flour) with the addition of Pangium edule seeds to provide a color similar to the intervention product (MECs).
Consume daily, 75 gram/day, during pregnancy (from 8-14 weeks gestation to delivery) and lactation (from delivery to 5 months post-partum).
Intervention: Placebo (Dietary Supplement)
Outcomes
Primary Outcomes
Birth length
Time Frame: 24 hours after birth
All measurements will be taken to the nearest millimetre (mm) using standardized techniques and trained anthropometrists using a portable infantometer (SECA 417, measuring range: 10-100 cm). The measurements will be made on nude infants and will be recorded in duplicate, or triplicate if the difference between the first and second measurement is more than the recommended range (i.e., 7 mm).
Attained linear growth and growth velocity
Time Frame: 5 months (+/- 1 week) post partum
All length measurement will be taken to the nearest millimetre (mm) using standardized techniques by trained anthropometrists using a portable infantometer (SECA 417, measuring range: 10-100 cm) The measurements will be made on nude infants and will be recorded in duplicate, or triplicate if the difference between the first and second measurement is more than the recommended range (i.e., 7 mm).
Secondary Outcomes
- Birth weight(24 hours after birth)
- Maternal haemoglobin level(35-36 gestational age and 5 months (+/- 1 week) post partum)
- Maternal food intake(35-36 weeks gestational age, 2 months (+/- 1 week) and 5 months (+/- 1 week) post partum)
- Infant breast milk micronutrient intake(5 months (+/- 1 week) post partum)
- Maternal micronutrient status(35-36 weeks gestational age and 5 months (+/- 1 week) post partum)
- Breast milk micronutrient concentration(5 months (+/- 1 week) post partum)
- Status of breastfed infants (exclusive vs. non-exclusive) and breast milk volume(5 months (+/- 1 week) post partum)
- Infant micronutrient status(5 months (+/- 1 week) post partum)
- Morbidity incidence rate of mothers and infant(14 weeks and 31-32 weeks gestational age, 1 month (+/- 1 week) and 4 months (+/- 1 week) post partum)