Clinical trial NCT04564222: Sustainable Intervention of Supplementation to Improve Kid's Growth Study
Official title: Double-Blind Cluster Randomized Controlled Trial of Chicken Liver and Eggshell Crackers in Mothers During Pregnancy and Lactation in a Disadvantaged Setting in Indonesia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Birth Length
Linear Growth
Micronutrients
Dietary Intakes
Keywords: Chicken Liver
Eggshell
Crackers
Pregnancy
Lactating Mother
Indonesia
Lead sponsor: SEAMEO Regional Centre for Food and Nutrition
Sponsor class: OTHER
Collaborators: name: Universitas Padjadjaran
name: University of Otago
name: USDA, Western Human Nutrition Research Center
name: VitMin Lab
name: International Food Policy Research Institute
First posted: 2020-09-25
Enrollment: 324
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A total of 324 pregnant women will be recruited from 28 clusters (villages) and will be randomised to either intervention or control using a randomized sequence, stratified by villages with \< 100 and ≥ 100 infants using block sizes of 2 and 4. Selected pregnant women from these villages will receive daily interventions in the form of 75 gram food products, made from chicken liver and chicken eggshells (Micronutrient-enriched Crackers/MEC) or placebo. The MEC and placebo will be given from 8-14 weeks gestation to 5 months' post-partum.
Primary purpose: PREVENTION

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).

Eligibility criteria: 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

Primary outcomes:
measure: Birth length
timeFrame: 24 hours after birth
measure: Attained linear growth and growth velocity
timeFrame: 5 months (+/- 1 week) post partum
Secondary outcomes:
measure: Birth weight
timeFrame: 24 hours after birth
measure: Maternal haemoglobin level
timeFrame: 35-36 gestational age and 5 months (+/- 1 week) post partum
measure: Maternal food intake
timeFrame: 35-36 weeks gestational age, 2 months (+/- 1 week) and 5 months (+/- 1 week) post partum
measure: Status of breastfed infants (exclusive vs. non-exclusive) and breast milk volume
timeFrame: 5 months (+/- 1 week) post partum
measure: Breast milk micronutrient concentration
timeFrame: 5 months (+/- 1 week) post partum
measure: Infant breast milk micronutrient intake
timeFrame: 5 months (+/- 1 week) post partum
measure: Maternal micronutrient status
timeFrame: 35-36 weeks gestational age and 5 months (+/- 1 week) post partum
measure: Infant micronutrient status
timeFrame: 5 months (+/- 1 week) post partum
measure: Morbidity incidence rate of mothers and infant
timeFrame: 14 weeks and 31-32 weeks gestational age, 1 month (+/- 1 week) and 4 months (+/- 1 week) post partum
Other outcomes:
Locations:
city: Sumedang
country: Indonesia
facility: Tanjungsari, Pamulihan, and Sukasari Subdistrict
state: West Java
Study officials:
affiliation: SEAMEO Regional Centre for Food and Nutrition
name: Aly Diana, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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