Sustainable Intervention of Supplementation to Improve Kid's Growth Study (NCT04564222) | Clinical Trial Compass
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Sustainable Intervention of Supplementation to Improve Kid's Growth Study
Indonesia324 participantsStarted 2020-11-11
Plain-language 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.
Who can participate
Age range
19 Years – 35 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Birth length
Timeframe: 24 hours after birth
2
Attained linear growth and growth velocity
Timeframe: 5 months (+/- 1 week) post partum
Trial details
NCT IDNCT04564222
SponsorSEAMEO Regional Centre for Food and Nutrition