Birth LengthSISTIK-GNCT04564222

Sustainable Intervention of Supplementation to Improve Kid's Growth Study

A study testing Micronutrient Enriched Crackers (MECs) in people with Birth Length and Linear Growth, run by SEAMEO Regional Centre for Food and Nutrition at 1 site in Indonesia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 19 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for: Birth Length, Linear Growth, Micronutrients
What is being tested?: Micronutrient Enriched Crackers (MECs)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 324 participants
Where: 1 siteIndonesia
Study dates: 11 Nov 2020to 31 Dec 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 to 35 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

Indonesia1 site

Tanjungsari, Pamulihan, and Sukasari Subdistrict
Sumedang, West Java

Other trials in Indonesia

About this 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

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.

Read the 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).

Conditions: Birth Length, Linear Growth, Micronutrients, Dietary Intakes
Being tested: Micronutrient Enriched Crackers (MECs), Placebo
Keywords: Chicken Liver, Eggshell, Crackers, Pregnancy, Lactating Mother, Indonesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Micronutrient Enriched Crackers (MECs)Dietary supplement
Also called SISTIK
MECs are manufactured according to the Standard Operational Procedures which have been developed taking into account the Hazard Analysis and Critical Control Point (HACCP) to maintain quality and safety and ensure the "Ready-to-eat MEC products" are safe. Data on the micronutrient concentrations and any potential bacteriological (Salmonella sp is negative, Bacillus cereus, Enterobacteriaceae, and Coagulase positive streptococci level are considered safe) and chemical contaminants (Pb, Hg, Cd, As, and Sn are not detectable) in the MEC products have been obtained from analysis in the laboratory of Saraswanti Indo Genetech, which has been accredited by KAN LP-184-IDN with SNI ISO/IEC 17025: 2008. Laboratory analysis of MEC products will be repeated at the middle and the end of the RCT to check on the quality and safety of the MEC product.
PlaceboDietary supplement
Placebo crackers are manufactured according to SOPs which have been developed taking into account the HACCP to maintain quality and safety and ensure the "Ready-to-eat placebo products" are safe. Data on the micronutrient concentrations and any potential bacteriological (Salmonella sp is negative, Bacillus cereus, Enterobacteriaceae, and Coagulase positive streptococci level are considered safe) and chemical contaminants (Pb, Hg, Cd, As, and Sn are not detected) in the placebo have been obtained based on the analysis in the laboratory of Saraswanti Indo Genetech, which has been accredited by KAN LP-184-IDN with SNI ISO/IEC 17025: 2008. Laboratory analysis of placebo samples will be repeated at the middle and the end of the RCT to check on the quality and safety of the placebo product.

Study groups in NCT04564222
Study group	Role	What they receive
Micronutrient Enriched Crackers (MECs)	Experimental	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). Receives: Dietary Supplement: Micronutrient Enriched Crackers (MECs)
Placebo	Placebo comparator	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). Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Birth length
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).
Measured: 24 hours after birth
Attained linear growth and growth velocity
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).
Measured: 5 months (+/- 1 week) post partum

Secondary outcomes (9)

Birth weight
All weight measurements will be taken to the nearest 10 grams using standardized protocols by trained anthropometrists using an electronic scale (SECA 334). 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., 100g).
Measured: 24 hours after birth
Maternal haemoglobin level
Blood will be taken by a trained personnel and hemoglobin concentration (g/dL) in the mother will be analysed by complete blood count in a certified laboratory (Prodia Laboratory; Sysmex XN-1000).
Measured: 35-36 gestational age and 5 months (+/- 1 week) post partum
Maternal food intake
Weighed records will be collected by the mothers on 3 non-consecutive days: 2 weekdays and 1 weekend day using a digital scale with precision of 4 grams (Kitchen Scale EK3131). On the next day after each weighed food record has been completed by the mother, an experienced research assistant will conduct a 24-hour recall on the mother using telephone/online communication. Results from the weighed record and recall will be combined to determine maternal food intake, which will be converted into nutrient intakes based on the weight and nutritional value of each food using the Indonesian Food Composition Table. The Multiple Source Method (MSM) program will be applied to estimate individual usual intakes of energy and nutrients as well as the usual intake distributions for the study population.
Measured: 35-36 weeks gestational age, 2 months (+/- 1 week) and 5 months (+/- 1 week) post partum
Status of breastfed infants (exclusive vs. non-exclusive) and breast milk volume
The deuterium dose-to-the mother technique will be performed to measure the volume of breast milk consumed by the infants and the status of breastfed infants. As much as 30 grams of Deuterium Oxide (D2O) are taken by the mother orally, which is then excreted into the breast milk consumed by the infant. Saliva sampling will be carried out according to protocol guidelines established by the International Atomic Energy Agency (IAEA; Human Health Series No. 7) with some adjustments to the number of days of sampling. Maternal and infant saliva samples will be taken on the 0th day before the mother is given D2O dose, and subsequently post-dose on day 2 or 3, day 8 or 9, and on day 13 or 14. A total of 2 mL of maternal and 1 mL of infant saliva will be collected on each sampling day. Saliva will be analyzed using Fourier Transform Infrared Spectrometry (FTIR), from which exclusive breastfeeding categorization and breast milk volume will be calculated using the Microsoft Excel Spreadsheet.
Measured: 5 months (+/- 1 week) post partum
Breast milk micronutrient concentration
Full breast milk samples will be collected by mothers from one breast (washed with distilled, deionised water) using acid washed breast milk pumps (Medela Harmony Manual Breast Pump) into acid washed glass bottles. Mothers will be requested to refrain from breastfeeding on one breast at least 2 hours before the scheduled breast milk collection to allow for the collection of fore- and hindmilk.
Breast milk micronutrient concentrations, including Na, Mg, P, K, Ca, Fe, Cu, Zn, Se will be analysed using ICP- MS Agilent 7900; Free Thiamine, TMP, and TPP using HPLC-FLD Agilent 1200; Cobalamin using Competitive Chemiluminescent Enzyme Immunase IMMULITE 1000; Riboflavin, FAD, FMN, NAD, panthothenic acid, pyridoxal, pyridoxine, biotin using UPLC-MS with a Waters ACQUITY UPLC I-Class system coupled to a Sciex 4500 triple quadrupole mass spectrometer; Performed retinol, Alpha-carotene, Beta-carotene, Beta-cryptoxanthin, Alpha- tocopherol, and Gamma-tocopherol using HPLC Agilent 1260.
Measured: 5 months (+/- 1 week) post partum
Infant breast milk micronutrient intake
Data generated from the volume of infant's breast milk intake using Deuterium Oxide Dose-to- Mother Technique and analyzed breast milk micronutrient concentrations will be used to calculate breast milk micronutrient intakes of the infants at 5 months post-partum.
Measured: 5 months (+/- 1 week) post partum
Maternal micronutrient status
Data generated from maternal micronutrient concentrations in serum (Ferritin, Soluble Transferrin Receptor (sTfR), Retinol-Binding Protein (RBP), Zn, and Se) and adjusted for inflammation status, where appropriate, using C-reactive protein and Alpha-1-acid glycoprotein will be used to assess maternal micronutrient status.
The cutoffs used to define deficiency for each maternal biomarker will be as follows: adjusted serum ferritin, < 15 μg/L; adjusted sTfR, > 8.3 mg/L; adjusted zinc < 10.7 μmol/L; adjusted RBP < 1.20 μmol/L; and adjusted selenium < 0.82 μmol/L.
Measured: 35-36 weeks gestational age and 5 months (+/- 1 week) post partum
Infant micronutrient status
Data generated from infant's serum micronutrient concentrations (Ferritin, sTfR, RBP, Zn, and Se) at 5 months post- partum, adjusted for inflammation status, where appropriate using C-reactive protein and Alpha-1-acid glycoprotein will be used to assess infant micronutrient status at 5 months post-partum.
The cutoffs used to define deficiency for each biomarker among the infants will be as follows: adjusted ferritin, < 12 μg/ L, adjusted sTfR, > 8.3 mg/L; adjusted zinc < 9.9 μmol/L; adjusted RBP < 0.83 μmol/L (27); adjusted selenium < 0.82 μmol/L; vitamin B12 < 148 pmol/L.
Measured: 5 months (+/- 1 week) post partum
Morbidity incidence rate of mothers and infant
The morbidity calendar for both mother and infant will be recorded by respondents independently and checked by research cadres once a week. The maternal morbidity calendar will be recorded over one month (for seizure, fever, headache, diarrhea, vaginal bleeding, cough, sore throat) at 14 weeks and 31-32 weeks of gestation, and 1 month and 4 months post-partum (for diarrhea, fever, cold, cough, vomit, ear infection, sore throat). The infant morbidity calendar will also be recorded over one month when the infant is 1 month and 4 months post-partum (for diarrhoea, fever, cold, cough, vomit, ear infection, sore throat). Digital thermometers will be provided to the respondents for self assessment of maternal and infant fever.
Measured: 14 weeks and 31-32 weeks gestational age, 1 month (+/- 1 week) and 4 months (+/- 1 week) post partum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Nov 202031 Dec 2024

First posted25 Sep 2020
Study start11 Nov 2020
Primary completion20 Feb 2024
Study completion31 Dec 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (22)Papers the sponsor has linked to this study.
Other trials for Birth LengthStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
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.
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 324 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04564222
Sponsor's protocol ID: 216447/Z/19/Z
Acronym: SISTIK-G
Status last verified: Mar 2024
First submitted: 20 Sep 2020
Last updated: 12 Mar 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Birth length and birth weight to analyse factors associated with stunting, underweight, and wasting; exclusively breastfed infant status confirmed by deuterium oxide dose to mother technique; micronutrient status of the lactating mother and their infant; maternal dietary intake and prevalence of inadequate intakes during pregnancy and lactation; the volume of exclusively breastfed infants and non-compliers; micronutrient concentrations of breastmilk; the effectiveness of MEC during pregnancy and lactation.

Publications

Daniels L, Gibson RS, Diana A, Haszard JJ, Rahmannia S, Luftimas DE, Hampel D, Shahab-Ferdows S, Reid M, Melo L, Lamers Y, Allen LH, Houghton LA. Micronutrient intakes of lactating mothers and their association with breast milk concentrations and micronutrient adequacy of exclusively breastfed Indonesian infants. Am J Clin Nutr. 2019 Aug 1;110(2):391-400. doi: 10.1093/ajcn/nqz047.
PubMed 31152543
Diana A, Haszard JJ, Purnamasari DM, Nurulazmi I, Luftimas DE, Rahmania S, Nugraha GI, Erhardt J, Gibson RS, Houghton L. Iron, zinc, vitamin A and selenium status in a cohort of Indonesian infants after adjusting for inflammation using several different approaches. Br J Nutr. 2017 Nov;118(10):830-839. doi: 10.1017/S0007114517002860.
PubMed 29189196
Diana A, Mallard SR, Haszard JJ, Purnamasari DM, Nurulazmi I, Herliani PD, Nugraha GI, Gibson RS, Houghton L. Consumption of fortified infant foods reduces dietary diversity but has a positive effect on subsequent growth in infants from Sumedang district, Indonesia. PLoS One. 2017 Apr 20;12(4):e0175952. doi: 10.1371/journal.pone.0175952. eCollection 2017.
PubMed 28426828
Domellof M, Dewey KG, Lonnerdal B, Cohen RJ, Hernell O. The diagnostic criteria for iron deficiency in infants should be reevaluated. J Nutr. 2002 Dec;132(12):3680-6. doi: 10.1093/jn/132.12.3680.
PubMed 12468607
Dror DK, Allen LH. Overview of Nutrients in Human Milk. Adv Nutr. 2018 May 1;9(suppl_1):278S-294S. doi: 10.1093/advances/nmy022.
PubMed 29846526
Dror DK, Allen LH. Retinol-to-Fat Ratio and Retinol Concentration in Human Milk Show Similar Time Trends and Associations with Maternal Factors at the Population Level: A Systematic Review and Meta-Analysis. Adv Nutr. 2018 May 1;9(suppl_1):332S-346S. doi: 10.1093/advances/nmy021.
PubMed 29846525
Duizer LM, Diana A, Rathomi HS, Luftimas DE, Rahmannia S, Santi W, Nugraha GI, Haszard JJ, Gibson RS, Houghton LA. An Acceptability Trial of Desiccated Beef Liver and Meat Powder as Potential Fortifiers of Complementary Diets of Young Children in Indonesia. J Food Sci. 2017 Sep;82(9):2206-2212. doi: 10.1111/1750-3841.13807. Epub 2017 Jul 26.
PubMed 28746725
Engle-Stone R, Haskell MJ, Ndjebayi AO, Nankap M, Erhardt JG, Gimou MM, Brown KH. Plasma retinol-binding protein predicts plasma retinol concentration in both infected and uninfected Cameroonian women and children. J Nutr. 2011 Dec;141(12):2233-41. doi: 10.3945/jn.111.145805. Epub 2011 Nov 2.
PubMed 22049292
Gibson RS, Hotz C. Dietary diversification/modification strategies to enhance micronutrient content and bioavailability of diets in developing countries. Br J Nutr. 2001 May;85 Suppl 2:S159-66. doi: 10.1079/bjn2001309.
PubMed 11509105
Human energy requirements: report of a joint FAO/ WHO/UNU Expert Consultation. Food Nutr Bull. 2005 Mar;26(1):166. No abstract available.
PubMed 15810802
Institute of Medicine (US) Panel on Micronutrients. Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium, and Zinc. Washington (DC): National Academies Press (US); 2001. Available from http://www.ncbi.nlm.nih.gov/books/NBK222310/
PubMed 25057538
Institute of Medicine (US) Committee to Review Dietary Reference Intakes for Vitamin D and Calcium; Ross AC, Taylor CL, Yaktine AL, Del Valle HB, editors. Dietary Reference Intakes for Calcium and Vitamin D. Washington (DC): National Academies Press (US); 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK56070/
PubMed 21796828
International Zinc Nutrition Consultative Group (IZiNCG); Brown KH, Rivera JA, Bhutta Z, Gibson RS, King JC, Lonnerdal B, Ruel MT, Sandtrom B, Wasantwisut E, Hotz C. International Zinc Nutrition Consultative Group (IZiNCG) technical document #1. Assessment of the risk of zinc deficiency in populations and options for its control. Food Nutr Bull. 2004 Mar;25(1 Suppl 2):S99-203. No abstract available.
PubMed 18046856
Liu Z, Diana A, Slater C, Preston T, Gibson RS, Houghton L, Duffull SB. Development of a nonlinear hierarchical model to describe the disposition of deuterium in mother-infant pairs to assess exclusive breastfeeding practice. J Pharmacokinet Pharmacodyn. 2019 Feb;46(1):1-13. doi: 10.1007/s10928-018-9613-x. Epub 2018 Nov 14.
PubMed 30430351
Liu Z, Diana A, Slater C, Preston T, Gibson RS, Houghton L, Duffull SB. Development of a Parsimonious Design for Optimal Classification of Exclusive Breastfeeding. CPT Pharmacometrics Syst Pharmacol. 2019 Aug;8(8):596-605. doi: 10.1002/psp4.12428. Epub 2019 Jul 3.
PubMed 31215140

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04564222
Acronym / sponsor ID: SISTIK-G / 216447/Z/19/Z
Conditions: Birth Length, Linear Growth, Micronutrients, Dietary Intakes
Keywords: Chicken Liver, Eggshell, Crackers, Pregnancy, Lactating Mother, Indonesia
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 324 participants (actual)
Lead sponsor: SEAMEO Regional Centre for Food and NutritionUniversity, hospital or other
Collaborators: Universitas Padjadjaran, University of Otago, USDA, Western Human Nutrition Research Center, VitMin Lab, International Food Policy Research Institute
Study start: 11 Nov 2020 (actual)
Primary completion: 20 Feb 2024 (actual)
Study completion: 31 Dec 2024 (estimated)
First posted: 25 Sep 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study is funded by the UK Wellcome Trust, the grant reference number is 216447/Z/19/Z.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2
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.

Arm	Type	Receives
Micronutrient Enriched Crackers (MECs)	Experimental	Dietary Supplement: 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).
Placebo	Placebo comparator	Dietary Supplement: PlaceboPlacebo 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).

Who may qualify

Ages: 19 to 35 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Micronutrient Enriched Crackers (MECs)Also: SISTIKMECs are manufactured according to the Standard Operational Procedures which have been developed taking into account the Hazard Analysis and Critical Control Point (HACCP) to maintain quality and safety and ensure the "Ready-to-eat MEC products" are safe. Data on the micronutrient concentrations and any potential bacteriological (Salmonella sp is negative, Bacillus cereus, Enterobacteriaceae, and Coagulase positive streptococci level are considered safe) and chemical contaminants (Pb, Hg, Cd, As, and Sn are not detectable) in the MEC products have been obtained from analysis in the laboratory of Saraswanti Indo Genetech, which has been accredited by KAN LP-184-IDN with SNI ISO/IEC 17025: 2008. Laboratory analysis of MEC products will be repeated at the middle and the end of the RCT to check on the quality and safety of the MEC product.	Dietary supplement	Micronutrient Enriched Crackers (MECs)
PlaceboPlacebo crackers are manufactured according to SOPs which have been developed taking into account the HACCP to maintain quality and safety and ensure the "Ready-to-eat placebo products" are safe. Data on the micronutrient concentrations and any potential bacteriological (Salmonella sp is negative, Bacillus cereus, Enterobacteriaceae, and Coagulase positive streptococci level are considered safe) and chemical contaminants (Pb, Hg, Cd, As, and Sn are not detected) in the placebo have been obtained based on the analysis in the laboratory of Saraswanti Indo Genetech, which has been accredited by KAN LP-184-IDN with SNI ISO/IEC 17025: 2008. Laboratory analysis of placebo samples will be repeated at the middle and the end of the RCT to check on the quality and safety of the placebo product.	Dietary supplement	Placebo

Primary outcome

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).

9 secondary outcomes

Birth weight
Time frame: 24 hours after birth
Maternal haemoglobin level
Time frame: 35-36 gestational age and 5 months (+/- 1 week) post partum
Maternal food intake
Time frame: 35-36 weeks gestational age, 2 months (+/- 1 week) and 5 months (+/- 1 week) post partum
Status of breastfed infants (exclusive vs. non-exclusive) and breast milk volume
Time frame: 5 months (+/- 1 week) post partum
Breast milk micronutrient concentration
Time frame: 5 months (+/- 1 week) post partum
Infant breast milk micronutrient intake
Time frame: 5 months (+/- 1 week) post partum
Maternal micronutrient status
Time frame: 35-36 weeks gestational age and 5 months (+/- 1 week) post partum
Infant micronutrient status
Time frame: 5 months (+/- 1 week) post partum
Morbidity incidence rate of mothers and infant
Time frame: 14 weeks and 31-32 weeks gestational age, 1 month (+/- 1 week) and 4 months (+/- 1 week) post partum

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
Background: PubMed 31152543Daniels L, Gibson RS, Diana A, Haszard JJ, Rahmannia S, Luftimas DE, Hampel D, Shahab-Ferdows S, Reid M, Melo L, Lamers Y, Allen LH, Houghton LA. Micronutrient intakes of lactating mothers and their association with breast milk concentrations and micronutrient adequacy of exclusively breastfed Indonesian infants. Am J Clin Nutr. 2019 Aug 1;110(2):391-400. doi: 10.1093/ajcn/nqz047.
Background: PubMed 29189196Diana A, Haszard JJ, Purnamasari DM, Nurulazmi I, Luftimas DE, Rahmania S, Nugraha GI, Erhardt J, Gibson RS, Houghton L. Iron, zinc, vitamin A and selenium status in a cohort of Indonesian infants after adjusting for inflammation using several different approaches. Br J Nutr. 2017 Nov;118(10):830-839. doi: 10.1017/S0007114517002860.
Background: PubMed 28426828Diana A, Mallard SR, Haszard JJ, Purnamasari DM, Nurulazmi I, Herliani PD, Nugraha GI, Gibson RS, Houghton L. Consumption of fortified infant foods reduces dietary diversity but has a positive effect on subsequent growth in infants from Sumedang district, Indonesia. PLoS One. 2017 Apr 20;12(4):e0175952. doi: 10.1371/journal.pone.0175952. eCollection 2017.
Background: PubMed 12468607Domellof M, Dewey KG, Lonnerdal B, Cohen RJ, Hernell O. The diagnostic criteria for iron deficiency in infants should be reevaluated. J Nutr. 2002 Dec;132(12):3680-6. doi: 10.1093/jn/132.12.3680.
Background: PubMed 29846526Dror DK, Allen LH. Overview of Nutrients in Human Milk. Adv Nutr. 2018 May 1;9(suppl_1):278S-294S. doi: 10.1093/advances/nmy022.
Background: PubMed 29846525Dror DK, Allen LH. Retinol-to-Fat Ratio and Retinol Concentration in Human Milk Show Similar Time Trends and Associations with Maternal Factors at the Population Level: A Systematic Review and Meta-Analysis. Adv Nutr. 2018 May 1;9(suppl_1):332S-346S. doi: 10.1093/advances/nmy021.
Background: PubMed 28746725Duizer LM, Diana A, Rathomi HS, Luftimas DE, Rahmannia S, Santi W, Nugraha GI, Haszard JJ, Gibson RS, Houghton LA. An Acceptability Trial of Desiccated Beef Liver and Meat Powder as Potential Fortifiers of Complementary Diets of Young Children in Indonesia. J Food Sci. 2017 Sep;82(9):2206-2212. doi: 10.1111/1750-3841.13807. Epub 2017 Jul 26.
Background: PubMed 22049292Engle-Stone R, Haskell MJ, Ndjebayi AO, Nankap M, Erhardt JG, Gimou MM, Brown KH. Plasma retinol-binding protein predicts plasma retinol concentration in both infected and uninfected Cameroonian women and children. J Nutr. 2011 Dec;141(12):2233-41. doi: 10.3945/jn.111.145805. Epub 2011 Nov 2.
Background: PubMed 11509105Gibson RS, Hotz C. Dietary diversification/modification strategies to enhance micronutrient content and bioavailability of diets in developing countries. Br J Nutr. 2001 May;85 Suppl 2:S159-66. doi: 10.1079/bjn2001309.
Background: PubMed 15810802Human energy requirements: report of a joint FAO/ WHO/UNU Expert Consultation. Food Nutr Bull. 2005 Mar;26(1):166. No abstract available.
Background: PubMed 25057538Institute of Medicine (US) Panel on Micronutrients. Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium, and Zinc. Washington (DC): National Academies Press (US); 2001. Available from http://www.ncbi.nlm.nih.gov/books/NBK222310/
Background: PubMed 21796828Institute of Medicine (US) Committee to Review Dietary Reference Intakes for Vitamin D and Calcium; Ross AC, Taylor CL, Yaktine AL, Del Valle HB, editors. Dietary Reference Intakes for Calcium and Vitamin D. Washington (DC): National Academies Press (US); 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK56070/
International Atomic Energy Agency. Stable isotope technique to assess intake of human milk in breastfed infants. Human Health Series No. 7. Vienna: IAEA, 2010.Link provided by the sponsor.
World Health Organization. Serum ferritin concentrations for the assessment of iron status and iron deficiency in populations. Vitamin and Mineral Nutrition Information System. Geneva: WHO, 2011 (WHO/NMH/NHD/MNM/112).Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Birth length and birth weight to analyse factors associated with stunting, underweight, and wasting; exclusively breastfed infant status confirmed by deuterium oxide dose to mother technique; micronutrient status of the lactating mother and their infant; maternal dietary intake and prevalence of inadequate intakes during pregnancy and lactation; the volume of exclusively breastfed infants and non-compliers; micronutrient concentrations of breastmilk; the effectiveness of MEC during pregnancy and lactation.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Aly Diana, PhD principal investigator

SEAMEO Regional Centre for Food and Nutrition

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Micronutrient Enriched Crackers (MECs) in people with Birth Length and Linear Growth, run by SEAMEO Regional Centre for Food and Nutrition at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Birth length (time frame: 24 hours after birth). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04564222, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.