The MOM-CARE Trial : Evaluating Antenatal and Postnatal MMSPlus for Improved Infant Birth and Growth Outcomes
NCT ID: NCT07029282
Last Updated: 2025-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
3000 participants
INTERVENTIONAL
2025-07-08
2027-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The main questions it aims to answer are:
1. Does MMS Plus during pregnancy reduce the risk of poor infant outcomes compared to standard MMS, as measured on a 5-point ordinal scale ranging from perinatal mortality to term birth with appropriate, small, or large-for-gestational-age infants?
2. Does postnatal MMS Plus improve infant length velocity at 6 months of age among exclusively breastfed infants compared to standard MMS and iron/folic acid (IFA) supplementation?
Researchers will compare:
1. MMS Plus versus standard MMS during pregnancy (antenatal phase)
2. MMS Plus versus standard MMS versus IFA after birth (postnatal phase)
Participants will:
1. Be randomly assigned to receive either MMS Plus or standard MMS during pregnancy
2. Be re-randomized after delivery to receive either MMS Plus, standard MMS, or IFA supplements during the postnatal period
3. Receive supplements under double-blind conditions
4. Be followed through childbirth and until the infant is 6 months of age
5. Attend regular clinic visits for health monitoring, infant assessments, and data collection.
This phase III adaptive randomized controlled trial will occur in three peri-urban catchment areas of Karachi, Pakistan.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Liposomal Iron 30 mg Supplement in Non-anemic Pregnant Females
NCT06669052
Vitamin D for Preventing Recurrent Preeclampsia in Pregnant Women
NCT07288801
Perinatal Infections in Pakistan
NCT00070746
RCT on the Efficacy of Methotrexate for the Prevention of GTD
NCT01984099
Microbiome and Malnutrition in Pregnancy (MMiP)
NCT05108675
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Study Phases and Design:
Antenatal Phase:
Pregnant women between 8-14 weeks of gestation will be enrolled and randomized (1:1) into one of two arms:
MMS Plus (enhanced formulation) Standard MMS (UNIMMAP formulation)
Both groups will also receive standard antenatal care (ANC) and nutrition counseling. The primary endpoint is a composite 5-point ordinal scale of infant health at 28 days post-birth, which includes perinatal mortality and growth-for-gestational-age outcomes - Small for gestational age (SGA), Appropriate for Gestational Age (AGA) and Large for Gestational Age (LGA), along with preterm or term. The trial employs a Bayesian adaptive design, with interim analyses beginning after 500 participants have birth outcomes, and subsequent evaluations every 250 outcomes. The design allows early stopping for superiority or continuation based on posterior probabilities.
Postnatal Phase:
Women with live births will be re-randomised (1:1:1) within one week postpartum into one of three arms:
MMS Plus Standard MMS IFA (standard care)
All groups receive standard postnatal care and nutrition counselling. The primary endpoint is infant length velocity (cm/month) at 6 months among exclusively breastfed infants. Secondary outcomes include additional anthropometric measures and neurodevelopmental assessments. Adaptive analyses in this phase also begin after 500 infants have outcome data.
Interventions:
MMS Plus includes 22 micronutrients with additional components: choline (450 mg), DHA (200 mg), calcium (500 mg), and a higher dose of nicotinamide (118 mg NE).
Standard MMS follows the UNIMMAP formulation with 15 micronutrients. IFA includes 60 mg of iron and 400 mcg folic acid.
All supplements are administered daily via single-dose sachets, indistinguishable in packaging and taste to preserve blinding. Products are manufactured by Remington Pharma.
Setting and Recruitment:
The trial is implemented through the Clinical Trials Unit (CTU) of Aga Khan University. Recruitment will occur in three peri-urban catchment communities: Ali Akbar Shah Goth (AG), Bhains Colony (BH), and Qayyumabad (QB). Two sites (AG and BH) are located in District Malir and one (QB) in District East. These communities have been selected due to high burdens of maternal undernutrition and established surveillance systems through the Integrated Research Platform (IRP).
Pregnant women will be recruited during Antenatal Care (ANC) visits and confirmed eligible via ultrasound. Postnatal re-randomization occurs for women with eligible live-born infants. Follow-up includes scheduled home and clinic visits until 6 months postpartum. Participants will receive all clinical services and transportation free of charge.
Data Management and Monitoring:
Data will be collected using a digital platform developed on OpenSRP, enabling longitudinal tracking of mother-child dyads. Unique IDs link all clinical encounters and supplement adherence records. Data quality assurance includes weekly field audits, double-entry verification, and remote monitoring by the trial coordination team.
A Data Safety Monitoring Board (DSMB) will review interim results and safety data. Trial governance includes a Trial Management Group (TMG) and an independent Trial Steering Committee. All adverse events will be reported following institutional and national regulatory guidelines.
Scientific Rationale:
Despite global efforts to improve maternal and infant nutrition, Pakistan continues to report high levels of maternal anaemia, low birth weight, and childhood stunting. While MMS is being piloted for national scale-up, the evidence base for extended formulations remains limited, especially regarding postnatal supplementation. MMS Plus is hypothesised to offer superior outcomes due to its inclusion of neurodevelopmentally and metabolically relevant nutrients (choline, DHA, calcium, and high-dose nicotinamide). These additions are based on recent findings from the MUMTA trial and other global data highlighting their role in fetal brain development, infant growth, and maternal health.
This trial addresses critical knowledge gaps in the timing (antenatal vs. postnatal), formulation, and impact of micronutrient interventions, using robust adaptive methodologies to optimise power, efficiency, and ethical participant exposure.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
MMS
Once daily dose of MMS sachet + Standard ANC and nutrition counseling
MMS
Pregnant women in this arm will receive 6gms of MMS (UNIMAPP MMS) in a ready to use sachet form which includes 15 nutrients.
IFA
Once daily dose of IFA sachet + Standard postnatal care (PNC) and nutrition counseling
IFA
Pregnant women in this arm will receive 6gms of IFA (Iron/Folic Acid) in a ready to use sachet form which includes 2 nutrients.
MMS Plus
One daily sachet of MMS PLUS + Standard ANC and nutrition counseling
MMS Plus
Pregnant women in this arm will receive 6gms of MMS Plus in a ready to use sachet form which includes 18 nutrients.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MMS
Pregnant women in this arm will receive 6gms of MMS (UNIMAPP MMS) in a ready to use sachet form which includes 15 nutrients.
MMS Plus
Pregnant women in this arm will receive 6gms of MMS Plus in a ready to use sachet form which includes 18 nutrients.
IFA
Pregnant women in this arm will receive 6gms of IFA (Iron/Folic Acid) in a ready to use sachet form which includes 2 nutrients.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Singleton and viable fetus on ultrasound
* A resident of the catchment area for at least the last six months
* Plans to stay within the catchment area during the pregnancy duration, during delivery and after birth of the baby.
* Has provided voluntary written informed consent
* Birth weight available within 72 hours
* Intention to breastfeed for 6 months
* Resides in the study area for the duration of the trial
* Has provided voluntary written informed consent
Exclusion Criteria
* Women with pre-existing health conditions such as history of uncontrolled diabetes and hypertension or other chronic illnesses
* Substance abuse, such as recreational drugs or smoking tobacco. Women chewing tobacco will not be excluded.
Postnatal Phase::
* Congenital anomalies, birth defects, or severe neonatal complications
* Infants who are already receiving supplemental formula feeding or other nutritional supplements (except pre-lacteal feeding, vitamins, and medications)
* Infants whose mothers have conditions that significantly affect breastfeeding, such as severe postpartum depression, insufficient milk supply, or maternal use of medications that contraindicate breastfeeding
15 Years
49 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Vital Pakistan Trust
OTHER
Aga Khan University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Fyezah Jehan, MBBS; MSc
Role: PRINCIPAL_INVESTIGATOR
Aga Khan University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Peri-Urban Slums of Karachi (Ali Akber Shah, Bhains Colony)
Karachi, Sindh, Pakistan
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Amoroso L. Post-2015 Agenda and Sustainable Development Goals: Where Are We Now? Global Opportunities to Address Malnutrition in all Its Forms, Including Hidden Hunger. World Rev Nutr Diet. 2017;118:45-56. doi: 10.1159/000484334. Epub 2018 Apr 13.
GNR. The state of global nutrition. Development Initiatives Bristol (UK); 2021
UNICEF. National Nutrition Survey 2018. Key Findings Report Ministry of Health Services, Nutrition Wing, Regulation and Coordination, Government of Pakistan, Pakistan. 2019
WHO Recommendations on Antenatal Care for a Positive Pregnancy Experience. Geneva: World Health Organization; 2016. Available from http://www.ncbi.nlm.nih.gov/books/NBK409108/
Bourassa MW, Osendarp SJM, Adu-Afarwuah S, Ahmed S, Ajello C, Bergeron G, Black R, Christian P, Cousens S, de Pee S, Dewey KG, Arifeen SE, Engle-Stone R, Fleet A, Gernand AD, Hoddinott J, Klemm R, Kraemer K, Kupka R, McLean E, Moore SE, Neufeld LM, Persson LA, Rasmussen KM, Shankar AH, Smith E, Sudfeld CR, Udomkesmalee E, Vosti SA. Review of the evidence regarding the use of antenatal multiple micronutrient supplementation in low- and middle-income countries. Ann N Y Acad Sci. 2019 May;1444(1):6-21. doi: 10.1111/nyas.14121. Epub 2019 May 27.
Keats EC, Haider BA, Tam E, Bhutta ZA. Multiple-micronutrient supplementation for women during pregnancy. Cochrane Database Syst Rev. 2019 Mar 14;3(3):CD004905. doi: 10.1002/14651858.CD004905.pub6.
Related Links
Access external resources that provide additional context or updates about the study.
WHO, Malnutrition, 2021
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-10733-31927
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.