Newborn HealthPhase 3MOM-CARENCT07029282
The MOM-CARE Trial : Evaluating Antenatal and Postnatal MMSPlus for Improved Infant Birth and Growth Outcomes
A Phase 3 study testing MMS, MMS Plus and IFA in people with Newborn Health and Multiple Micronutrient Deficiencies During Pregnancy, run by Aga Khan University at 1 site in Pakistan.
Trial summary
This clinical trial aims to learn if MMS Plus improves infant health compared to standard MMS during pregnancy and the postnatal period in women living in peri-urban areas of Karachi, Pakistan. It will also evaluate how MMS Plus affects infant growth during the first 6 months of life. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Newborn Health, Multiple Micronutrient Deficiencies During Pregnancy, Nutrition During Pregnancy
- What is being tested?
- MMS, MMS Plus and IFA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 sitePakistan
- Study dates
- 8 Jul 2025to 31 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 15 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Gestational age confirmed by ultrasound to be 8-14 weeks
- 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
Show all 9Show fewer
- Intention to breastfeed for 6 months
- Resides in the study area for the duration of the trial
- Has provided voluntary written informed consent
Who cannot join
- Women with known allergies or intolerance to any components of the MMS or MMS PLUS being studied
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Peri-Urban Slums of Karachi (Ali Akber Shah, Bhains Colony)
Karachi, Sindh
Akber Madhwani, +92 21 111 911 911 ext. 4793, akber.madhwani@aku.edu
Fyezah Jehan, MSc
About this study
Official title: A Phase III Double-Blind, Adaptive Randomized Trial of Antenatal MMSPlus Versus UNIMAPP MMS and Postnatal MMSPlus Versus UNIMAPP MMS or IFA to Improve Infant Birth Outcomes and Growth at 6 Months
This clinical trial aims to learn if MMS Plus improves infant health compared to standard MMS during pregnancy and the postnatal period in women living in peri-urban areas of Karachi, Pakistan. It will also evaluate how MMS Plus affects infant growth during the first 6 months of life.
The main questions it aims to answer are:
Read more
- 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?
- 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:
- MMS Plus versus standard MMS during pregnancy (antenatal phase)
- MMS Plus versus standard MMS versus IFA after birth (postnatal phase)
Participants will:
- Be randomly assigned to receive either MMS Plus or standard MMS during pregnancy
- Be re-randomized after delivery to receive either MMS Plus, standard MMS, or IFA supplements during the postnatal period
- Receive supplements under double-blind conditions
- Be followed through childbirth and until the infant is 6 months of age
- 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.
Read the detailed description
This is a two-phase, Phase III double-blind, adaptive randomized controlled trial designed to evaluate the effects of enhanced multiple micronutrient supplementation (MMS Plus) compared to standard UNIMMAP MMS and iron/folic acid (IFA) supplementation on maternal and infant health outcomes in peri-urban Karachi, Pakistan. The trial is being conducted by The Aga Khan University and is funded by the Bill Gates Foundation.
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
- Newborn Health, Multiple Micronutrient Deficiencies During Pregnancy, Nutrition During Pregnancy, Adaptive Trial, Postnatal Growth, Neurodevelopment Outcome
- Being tested
- MMS, MMS Plus, IFA
- Keywords
- Antenatal Phase, Postnatal Phase, Micro Nutrient Supplementation, Infant Growth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMSDietary supplement
Also called UNIMAPP 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 PlusDrug
Pregnant women in this arm will receive 6gms of MMS Plus in a ready to use sachet form which includes 18 nutrients.
IFADietary supplement
Pregnant women in this arm will receive 6gms of IFA (Iron/Folic Acid) in a ready to use sachet form which includes 2 nutrients.
| Study group | Role | What they receive |
|---|---|---|
| MMS | Active comparator | Once daily dose of MMS sachet + Standard ANC and nutrition counseling Receives: Dietary Supplement: MMS |
| IFA | Active comparator | Once daily dose of IFA sachet + Standard postnatal care (PNC) and nutrition counseling Receives: Dietary Supplement: IFA |
| MMS Plus | Experimental | One daily sachet of MMS PLUS + Standard ANC and nutrition counseling Receives: Drug: MMS Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antenatal Phase: Composite Infant Health Score at 28 Days Post-Birth
Infant health will be assessed using a 5-point ordinal categorical scale, defined as follows:
Stillbirth, miscarriage, or early neonatal death (0-6 days); Preterm birth with Small for Gestational Age (SGA) infant; Preterm birth with Appropriate or Large for Gestational Age (AGA or LGA) infant; Term birth with SGA infant; Term birth with AGA or LGA infant Method of Aggregation: Proportion of participants in each outcome category Analysis Metric: Ordinal regression (e.g., Bayesian cumulative logistic regression)
Measured: 28 days after birth
Postnatal Phase: Infant linear growth velocity at 6 months
Infant linear growth velocity, calculated as:
Length Velocity (cm/month) = Length at 6 months - Length at birth / Age in days / 30.4 Only infants exclusively/predominantly breastfed through 6 months will be included in this analysis.
Method of Aggregation: Mean length velocity per intervention group Analysis Metric: Continuous variable; analysed using ANOVA or regression models with pairwise comparisons
Measured: Birth to 6 months
Secondary outcomes (14)
Gestational Weight Gain (GWG)
Change in maternal weight during pregnancy, measured in kilograms (kg) from baseline (enrollment) to the time of delivery.
Gestational weight gain will be reported both as:
Absolute weight gain (kg) Z-scores and percentiles, adjusted for gestational age, based on WHO or INTERGROWTH standards
Greater weight gain within recommended ranges is considered indicative of improved maternal nutritional status and better fetal outcomes.
Measured: At birth
Intrauterine Growth Restriction (IUGR)
Episodes of IUGR measured at two timepoints during antenatal phase measured through ultrasound to assess growth of fetus in relation to weight and size
Measured: GA 20 and 32 weeks
Gestational age at birth
Gestational age at birth, measured in completed weeks, will be assessed using first-trimester ultrasound dating (8-14 weeks gestation).
Higher gestational age indicates a better outcome in terms of fetal maturity and reduced risk of neonatal complications.
Method of aggregation: Mean gestational age (weeks); proportion of births in each gestational age category (preterm, term, post-term)
Measured: Within 72 hours of birth
Birth Weight (gm)
Weight of the newborn assess in gram to assess the difference between the arms
Measured: Within 72 hours of birth
Birth length (cm)
Length of the newborn assess in cm to assess the difference between the arms
Measured: within 72 hours of birth
Head circumference (cm)
Head circumference of the newborn assess in cm to assess the difference between the arms
Measured: within 72 hours of birth
Infant MUAC (cm)
Infant MUAC at birth of the newborn assess in cm to assess the difference between the arms
Measured: within 72 hours of birth
Neonatal Mortality
Neonatal mortality to assess the difference between arms
Measured: within the first 28 days of life
Infant weight velocity
Mean difference in growth velocity of >0.4 gram/kg/day to look at comparisons between multiple arms
Measured: 1, 2, 4, 6, 12, 24 months of life
Length-for-age z-score (LAZ)
Mean difference in LAZ >0.5 to look at comparisons between multiple arms
Measured: 2, 4, 6, 12, 24 months of life
Weight-for-age z-score (WAZ)
Mean difference in WAZ of >0.5 to look at comparisons between multiple arms
Measured: 2, 4, 6, 12, 24 months of life
Stunting, wasting and underweight Stunting <-2 LAZ ( Length for age Z) scores; Wasting <-2 WHZ (Weight for height Z) scores; underweight <-2WAZ (Weight for age Z) scores
Mean difference in LAZ, WHZ and WAZ scores to look at comparison between multiple arms
Measured: 2, 4, 6, 12, 24 months of life
Global Scale for Early Development (GSED) Assessment
Neurodevelopmental functioning will be assessed using the Global Scales for Early Development (GSED), a standardised instrument developed by the World Health Organisation to measure early child development across cognitive, motor, language, and socio-emotional domains.
The GSED yields a Developmental Score (D-score), which is a continuous score derived from observed developmental milestones.
Minimum Value: ~30 (varies slightly based on age and item completion)
Maximum Value: ~80
Interpretation: Higher scores indicate better neurodevelopmental status
Scores will be analysed as continuous variables and categorised into:
"On track"
"At risk"
"Developmental delay" based on GSED normative thresholds for age.
Measured: 6, 12 and 24 months of life
Infant Brain Morphology and Volume (MRI Assessment Using Hyperfine Portable MRI)
Infants enrolled in the postnatal phase will undergo brain imaging using the Hyperfine Swoop™ portable MRI system to assess brain morphology and total and regional brain volumes.
Imaging will be conducted at 6, 12, and 24 months of age.
Brain volume will be quantified in cubic centimetres (cc) for total brain, grey matter, white matter, and selected regions of interest (e.g., hippocampus, cerebellum).
Morphological features (e.g., sulcal/gyral patterns, ventricular size, myelination status) will be qualitatively described and coded using standardised radiological criteria.
Higher volumes and normal morphology are indicative of better neurodevelopmental outcomes.
Measured: 6, 12 and 24 months of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start8 Jul 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Newborn HealthStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- During the antenatal phase, participants will be randomized into one of two arms (MMS vs MMS Plus). However during the postnatal phase, those same participants will be re-randomized into three arms (MMS vs MMS Plus vs IFA).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- Vital Pakistan Trust
- Responsible party
- Sponsor
- Investigators
- Fyezah Jehan, MBBS; MSc, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07029282
- Sponsor's protocol ID
- 2024-10733-31927
- Acronym
- MOM-CARE
- Status last verified
- Oct 2025
- First submitted
- 23 May 2025
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It will most likely be shared, but it has not been decided how, yet.
Publications
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.
PubMed 33503779GNR. 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/
PubMed 28079998Bourassa 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.
PubMed 31134643Keats 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.
PubMed 30873598
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Double-Blind, Adaptive Randomized Trial of Antenatal MMSPlus Versus UNIMAPP MMS and Postnatal MMSPlus Versus UNIMAPP MMS or IFA to Improve Infant Birth Outcomes and Growth at 6 Months
- ClinicalTrials.gov ID
- NCT07029282
- Acronym / sponsor ID
- MOM-CARE / 2024-10733-31927
- Conditions
- Newborn Health, Multiple Micronutrient Deficiencies During Pregnancy, Nutrition During Pregnancy, Adaptive Trial, Postnatal Growth, Neurodevelopment Outcome
- Keywords
- Antenatal Phase, Postnatal Phase, Micro Nutrient Supplementation, Infant Growth
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- Vital Pakistan Trust
- Study start
- 8 Jul 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Jun 2025 (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 clinical trial aims to learn if MMS Plus improves infant health compared to standard MMS during pregnancy and the postnatal period in women living in peri-urban areas of Karachi, Pakistan. It will also evaluate how MMS Plus affects infant growth during the first 6 months of life.
The main questions it aims to answer are:
- 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?
- 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:
- MMS Plus versus standard MMS during pregnancy (antenatal phase)
- MMS Plus versus standard MMS versus IFA after birth (postnatal phase)
Participants will:
- Be randomly assigned to receive either MMS Plus or standard MMS during pregnancy
- Be re-randomized after delivery to receive either MMS Plus, standard MMS, or IFA supplements during the postnatal period
- Receive supplements under double-blind conditions
- Be followed through childbirth and until the infant is 6 months of age
- 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.
Detailed description
This is a two-phase, Phase III double-blind, adaptive randomized controlled trial designed to evaluate the effects of enhanced multiple micronutrient supplementation (MMS Plus) compared to standard UNIMMAP MMS and iron/folic acid (IFA) supplementation on maternal and infant health outcomes in peri-urban Karachi, Pakistan. The trial is being conducted by The Aga Khan University and is funded by the Bill Gates Foundation.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- During the antenatal phase, participants will be randomized into one of two arms (MMS vs MMS Plus). However during the postnatal phase, those same participants will be re-randomized into three arms (MMS vs MMS Plus vs IFA).
| Arm | Type | Receives |
|---|---|---|
| MMS | Active comparator | Dietary Supplement: MMSOnce daily dose of MMS sachet + Standard ANC and nutrition counseling |
| IFA | Active comparator | Dietary Supplement: IFAOnce daily dose of IFA sachet + Standard postnatal care (PNC) and nutrition counseling |
| MMS Plus | Experimental | Drug: MMS PlusOne daily sachet of MMS PLUS + Standard ANC and nutrition counseling |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Gestational age confirmed by ultrasound to be 8-14 weeks
- 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
Key exclusion criteria (7 listed)
- Women with known allergies or intolerance to any components of the MMS or MMS PLUS being studied
- 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.
- 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)
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 |
|---|---|---|
| MMSAlso: UNIMAPP MMSPregnant women in this arm will receive 6gms of MMS (UNIMAPP MMS) in a ready to use sachet form which includes 15 nutrients. | Dietary supplement | MMS |
| MMS PlusPregnant women in this arm will receive 6gms of MMS Plus in a ready to use sachet form which includes 18 nutrients. | Drug | MMS Plus |
| IFAPregnant women in this arm will receive 6gms of IFA (Iron/Folic Acid) in a ready to use sachet form which includes 2 nutrients. | Dietary supplement | IFA |
Primary outcome
Antenatal Phase: Composite Infant Health Score at 28 Days Post-Birth
Time frame: 28 days after birth
Infant health will be assessed using a 5-point ordinal categorical scale, defined as follows: Stillbirth, miscarriage, or early neonatal death (0-6 days); Preterm birth with Small for Gestational Age (SGA) infant; Preterm birth with Appropriate or Large for Gestational Age (AGA or LGA) infant; Term birth with SGA infant; Term birth with AGA or LGA infant Method of Aggregation: Proportion of participants in each outcome category Analysis Metric: Ordinal regression (e.g., Bayesian cumulative logistic regression)
Postnatal Phase: Infant linear growth velocity at 6 months
Time frame: Birth to 6 months
Infant linear growth velocity, calculated as: Length Velocity (cm/month) = Length at 6 months - Length at birth / Age in days / 30.4 Only infants exclusively/predominantly breastfed through 6 months will be included in this analysis. Method of Aggregation: Mean length velocity per intervention group Analysis Metric: Continuous variable; analysed using ANOVA or regression models with pairwise comparisons
14 secondary outcomes
Gestational Weight Gain (GWG)
Time frame: At birth
Intrauterine Growth Restriction (IUGR)
Time frame: GA 20 and 32 weeks
Gestational age at birth
Time frame: Within 72 hours of birth
Birth Weight (gm)
Time frame: Within 72 hours of birth
Birth length (cm)
Time frame: within 72 hours of birth
Head circumference (cm)
Time frame: within 72 hours of birth
Infant MUAC (cm)
Time frame: within 72 hours of birth
Neonatal Mortality
Time frame: within the first 28 days of life
Infant weight velocity
Time frame: 1, 2, 4, 6, 12, 24 months of life
Length-for-age z-score (LAZ)
Time frame: 2, 4, 6, 12, 24 months of life
Weight-for-age z-score (WAZ)
Time frame: 2, 4, 6, 12, 24 months of life
Stunting, wasting and underweight Stunting <-2 LAZ ( Length for age Z) scores; Wasting <-2 WHZ (Weight for height Z) scores; underweight <-2WAZ (Weight for age Z) scores
Time frame: 2, 4, 6, 12, 24 months of life
Global Scale for Early Development (GSED) Assessment
Time frame: 6, 12 and 24 months of life
Infant Brain Morphology and Volume (MRI Assessment Using Hyperfine Portable MRI)
Time frame: 6, 12 and 24 months of life
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- Results publication: PubMed 33503779Amoroso 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.
- Results publicationGNR. The state of global nutrition. Development Initiatives Bristol (UK); 2021
- Results publicationUNICEF. National Nutrition Survey 2018. Key Findings Report Ministry of Health Services, Nutrition Wing, Regulation and Coordination, Government of Pakistan, Pakistan. 2019
- Results publication: PubMed 28079998WHO Recommendations on Antenatal Care for a Positive Pregnancy Experience. Geneva: World Health Organization; 2016. Available from http://www.ncbi.nlm.nih.gov/books/NBK409108/
- Results publication: PubMed 31134643Bourassa 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.
- Results publication: PubMed 30873598Keats 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.
- WHO, Malnutrition, 2021Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. It will most likely be shared, but it has not been decided how, yet.
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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.
Fyezah Jehan, MBBS; MSc principal investigator
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MMS, MMS Plus and IFA in people with Newborn Health and Multiple Micronutrient Deficiencies During Pregnancy, run by Aga Khan University at 1 site in Pakistan.
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 9 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 7 Oct 2025. 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 Pakistan. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fyezah Jehan, MBBS; MSc (+9234930051 ext. 4793, fyezah.jehan@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antenatal Phase: Composite Infant Health Score at 28 Days Post-Birth (time frame: 28 days 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 NCT07029282, which also lists 6 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 7 Oct 2025.