Sustainable Intervention of Supplementation to Improve Kid's Growth Study (SISTIK-G)

SEAMEO Regional Centre for Food and Nutrition

Status: Active, not recruiting

Conditions: Micronutrients; Linear Growth; Dietary Intakes; Birth Length

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Micronutrient Enriched Crackers (MECs)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04564222

216447/Z/19/Z

Details and patient eligibility

About

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.

Full 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).

Enrollment: 324 patients

Sex: Female

Ages: 19 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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324 participants in 2 patient groups, including a placebo group

Micronutrient Enriched Crackers (MECs)

Experimental group

Description:

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).

Treatment:

Dietary Supplement: Micronutrient Enriched Crackers (MECs)

Placebo

Placebo Comparator group

Description:

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).

Treatment:

Dietary Supplement: Placebo