Maternal AnemiaNCT07665957
MMS, IFA, and MMS+IFA Supplementation in Pregnant Women
A study testing Multiple Micronutrient Supplementation (MMS) and Iron-Folic Acid (IFA) in people with Maternal Anemia and Micronutrient Deficiency, run by Sindh Institute of Child Health and Neonatology.
Trial summary
This study aims to compare the effectiveness of Multiple Micronutrient Supplementation (MMS), Iron-Folic Acid (IFA) supplementation, and combined MMS+IFA supplementation among pregnant women. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Anemia, Micronutrient Deficiency, Pregnancy Outcomes
- What is being tested?
- Multiple Micronutrient Supplementation (MMS) and Iron-Folic Acid (IFA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 402 participants
- Where
- No sites listed yet
- Study dates
- 25 Jun 2026to 25 Jan 2027
- Phase
- Interventional
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women aged 18 years or older
- Gestational age ≤20 weeks at enrollment
- Singleton pregnancy
- Hemoglobin concentration ≥10 g/dL at baseline
- Willing and able to provide informed consent
- Willing to comply with study procedures and follow-up visits
Who cannot join
- Severe anemia requiring injectable treatment (hemoglobin <7 g/dL)
- Pre-existing diabetes mellitus
- Pre-existing hypertension
- Renal disease
- Current therapeutic iron or micronutrient supplementation beyond routine antenatal supplementation
- Known fetal congenital anomalies
- Any medical condition that, in the opinion of the investigator, would interfere with study participation or outcome assessment
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparative Effectiveness of Multiple Micronutrient Supplementation (MMS), Iron-Folic Acid (IFA), and Combined MMS+IFA on Maternal Hemoglobin Levels and Neonatal Outcomes Among Pregnant Women: An Open-Label Randomized Controlled Trial
This study aims to compare the effectiveness of Multiple Micronutrient Supplementation (MMS), Iron-Folic Acid (IFA) supplementation, and combined MMS+IFA supplementation among pregnant women. Maternal anemia and micronutrient deficiencies are common during pregnancy and can adversely affect both maternal and neonatal health outcomes.
A total of 402 pregnant women with gestational age of 20 weeks or less will be randomly assigned to receive MMS, IFA, or combined MMS+IFA supplementation. Participants will be followed throughout pregnancy until delivery. Maternal hemoglobin levels, maternal compliance with supplementation, and neonatal outcomes including birth weight, preterm birth, APGAR scores, and congenital anomalies will be assessed.
The findings of this study will provide evidence to guide antenatal nutrition policies and practices in Pakistan.
Read the detailed description
Maternal micronutrient deficiencies remain a major public health concern in low- and middle-income countries, including Pakistan. Iron deficiency anemia, along with deficiencies of folate, vitamin D, vitamin B12, zinc, iodine, and other micronutrients, contributes substantially to adverse maternal and neonatal outcomes. Although routine Iron-Folic Acid (IFA) supplementation is recommended during pregnancy, it may not adequately address the broader spectrum of micronutrient deficiencies commonly observed among pregnant women.
Multiple Micronutrient Supplementation (MMS) has emerged as a comprehensive alternative that includes iron, folic acid, and additional essential vitamins and minerals required during pregnancy. Evidence from randomized controlled trials and systematic reviews suggests that MMS may improve selected neonatal outcomes; however, evidence regarding maternal hemoglobin improvement and compliance remains inconsistent across settings. Furthermore, limited data are available from Pakistan comparing MMS, IFA, and combined MMS+IFA supplementation.
This study is a three-arm, parallel-group, open-label randomized controlled trial conducted at the antenatal clinics of the Sindh Institute of Child Health and Neonatology (SICHN) in Karachi and Jamshoro, Pakistan. A total of 402 eligible pregnant women with gestational age ≤20 weeks and baseline hemoglobin ≥10 g/dL will be enrolled and randomized in a 1:1:1 ratio to receive either MMS, IFA, or combined MMS+IFA supplementation.
Maternal hemoglobin concentration will be measured at baseline, 28 weeks gestation, and 36-37 weeks gestation or delivery. Maternal compliance will be assessed using pill counts and self-reported supplement intake. Neonatal outcomes including birth weight, low birth weight, preterm birth, APGAR scores, and congenital anomalies will be evaluated at delivery.
The study aims to compare the effectiveness of MMS, IFA, and MMS+IFA supplementation on maternal hemoglobin levels, neonatal outcomes, and maternal compliance. Findings from this study will contribute to strengthening evidence-based antenatal nutrition policies and maternal health programs in Pakistan.
- Being tested
- Multiple Micronutrient Supplementation (MMS), Iron-Folic Acid (IFA)
- Keywords
- Multiple Micronutrient Supplementation, MMS, Iron Folic Acid, IFA, Pregnancy, Maternal Anemia, Maternal Hemoglobin, Maternal Nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple Micronutrient Supplementation (MMS)Dietary supplement
WHO-standard multiple micronutrient supplement containing iron, folic acid, zinc, iodine, vitamins A, D, C, and B-complex vitamins administered daily during pregnancy
Iron-Folic Acid (IFA)Dietary supplement
Iron 60 mg and folic acid 400 µg administered daily during pregnancy.
| Study group | Role | What they receive |
|---|---|---|
| MMS | Experimental | Multiple Micronutrient Supplementation (MMS) containing iron, folic acid, zinc, iodine, vitamins A, D, C, and B-complex vitamins administered daily during pregnancy. Receives: Dietary Supplement: Multiple Micronutrient Supplementation (MMS) |
| MMS + IFA | Experimental | Combined Multiple Micronutrient Supplementation (MMS) and Iron-Folic Acid (IFA) supplementation administered daily during pregnancy. Total iron and folic acid intake will remain within safe WHO-recommended limits Receives: Dietary Supplement: Multiple Micronutrient Supplementation (MMS); Dietary Supplement: Iron-Folic Acid (IFA) |
| IFA | Active comparator | Not described Receives: Dietary Supplement: Iron-Folic Acid (IFA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Hemoglobin Concentration
Maternal hemoglobin concentration measured using complete blood count (CBC) and compared between study groups.
Measured: Baseline, 28 weeks gestation, and 36-37 weeks gestation or at delivery
Secondary outcomes (1)
Birth Weight
Neonatal birth weight measured in grams within one hour of birth.
Measured: At birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start25 Jun 2026 (estimated)
- Primary completion25 Dec 2026 (estimated)
- Study completion25 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal AnemiaStudies 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
- Participants will be randomized in a 1:1:1 ratio to one of three parallel study arms: Multiple Micronutrient Supplementation (MMS), Iron-Folic Acid supplementation (IFA), or combined MMS+IFA supplementation. Participants will remain in their assigned intervention group throughout the study period until delivery.
- Masking
- None (open label)
- Enrolment
- 402 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sindh Institute of Child Health and Neonatology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sher Wali Khan, Sindh Institute of Child Health and Neonatology
- Investigators
- Rozina Feroz Ali, MBBS, MSC, Principal investigator, Sindh Institute of Child Health and Neonatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07665957
- Sponsor's protocol ID
- SICHN/IRB-011/2026
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At the time of study registration, no final decision has been made regarding the sharing of individual participant data (IPD). Any future data-sharing plan will be determined in accordance with institutional policies, ethical approvals, participant confidentiality requirements, and applicable regulatory requirements.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Multiple Micronutrient Supplementation (MMS), Iron-Folic Acid (IFA), and Combined MMS+IFA on Maternal Hemoglobin Levels and Neonatal Outcomes Among Pregnant Women: An Open-Label Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07665957
- Acronym / sponsor ID
- SICHN/IRB-011/2026
- Keywords
- Multiple Micronutrient Supplementation, MMS, Iron Folic Acid, IFA, Pregnancy, Maternal Anemia, Maternal Hemoglobin, Maternal Nutrition
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 402 participants (estimated)
- Lead sponsor
- Sindh Institute of Child Health and NeonatologyUniversity, hospital or other
- Study start
- 25 Jun 2026 (estimated)
- Primary completion
- 25 Dec 2026 (estimated)
- Study completion
- 25 Jan 2027 (estimated)
- First posted
- 24 Jun 2026 (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 aims to compare the effectiveness of Multiple Micronutrient Supplementation (MMS), Iron-Folic Acid (IFA) supplementation, and combined MMS+IFA supplementation among pregnant women. Maternal anemia and micronutrient deficiencies are common during pregnancy and can adversely affect both maternal and neonatal health outcomes.
A total of 402 pregnant women with gestational age of 20 weeks or less will be randomly assigned to receive MMS, IFA, or combined MMS+IFA supplementation. Participants will be followed throughout pregnancy until delivery. Maternal hemoglobin levels, maternal compliance with supplementation, and neonatal outcomes including birth weight, preterm birth, APGAR scores, and congenital anomalies will be assessed.
The findings of this study will provide evidence to guide antenatal nutrition policies and practices in Pakistan.
Detailed description
Maternal micronutrient deficiencies remain a major public health concern in low- and middle-income countries, including Pakistan. Iron deficiency anemia, along with deficiencies of folate, vitamin D, vitamin B12, zinc, iodine, and other micronutrients, contributes substantially to adverse maternal and neonatal outcomes. Although routine Iron-Folic Acid (IFA) supplementation is recommended during pregnancy, it may not adequately address the broader spectrum of micronutrient deficiencies commonly observed among pregnant women.
Multiple Micronutrient Supplementation (MMS) has emerged as a comprehensive alternative that includes iron, folic acid, and additional essential vitamins and minerals required during pregnancy. Evidence from randomized controlled trials and systematic reviews suggests that MMS may improve selected neonatal outcomes; however, evidence regarding maternal hemoglobin improvement and compliance remains inconsistent across settings. Furthermore, limited data are available from Pakistan comparing MMS, IFA, and combined MMS+IFA supplementation.
This study is a three-arm, parallel-group, open-label randomized controlled trial conducted at the antenatal clinics of the Sindh Institute of Child Health and Neonatology (SICHN) in Karachi and Jamshoro, Pakistan. A total of 402 eligible pregnant women with gestational age ≤20 weeks and baseline hemoglobin ≥10 g/dL will be enrolled and randomized in a 1:1:1 ratio to receive either MMS, IFA, or combined MMS+IFA supplementation.
Maternal hemoglobin concentration will be measured at baseline, 28 weeks gestation, and 36-37 weeks gestation or delivery. Maternal compliance will be assessed using pill counts and self-reported supplement intake. Neonatal outcomes including birth weight, low birth weight, preterm birth, APGAR scores, and congenital anomalies will be evaluated at delivery.
The study aims to compare the effectiveness of MMS, IFA, and MMS+IFA supplementation on maternal hemoglobin levels, neonatal outcomes, and maternal compliance. Findings from this study will contribute to strengthening evidence-based antenatal nutrition policies and maternal health programs in Pakistan.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be randomized in a 1:1:1 ratio to one of three parallel study arms: Multiple Micronutrient Supplementation (MMS), Iron-Folic Acid supplementation (IFA), or combined MMS+IFA supplementation. Participants will remain in their assigned intervention group throughout the study period until delivery.
| Arm | Type | Receives |
|---|---|---|
| MMS | Experimental | Dietary Supplement: Multiple Micronutrient Supplementation (MMS)Multiple Micronutrient Supplementation (MMS) containing iron, folic acid, zinc, iodine, vitamins A, D, C, and B-complex vitamins administered daily during pregnancy. |
| MMS + IFA | Experimental | Dietary Supplement: Multiple Micronutrient Supplementation (MMS), Dietary Supplement: Iron-Folic Acid (IFA)Combined Multiple Micronutrient Supplementation (MMS) and Iron-Folic Acid (IFA) supplementation administered daily during pregnancy. Total iron and folic acid intake will remain within safe WHO-recommended limits |
| IFA | Active comparator | Dietary Supplement: Iron-Folic Acid (IFA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pregnant women aged 18 years or older
- Gestational age ≤20 weeks at enrollment
- Singleton pregnancy
- Hemoglobin concentration ≥10 g/dL at baseline
- Willing and able to provide informed consent
Key exclusion criteria (7 listed)
- Severe anemia requiring injectable treatment (hemoglobin <7 g/dL)
- Pre-existing diabetes mellitus
- Pre-existing hypertension
- Renal disease
- Current therapeutic iron or micronutrient supplementation beyond routine antenatal supplementation
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 |
|---|---|---|
| Multiple Micronutrient Supplementation (MMS)WHO-standard multiple micronutrient supplement containing iron, folic acid, zinc, iodine, vitamins A, D, C, and B-complex vitamins administered daily during pregnancy | Dietary supplement | MMS, MMS + IFA |
| Iron-Folic Acid (IFA)Iron 60 mg and folic acid 400 µg administered daily during pregnancy. | Dietary supplement | IFA, MMS + IFA |
Primary outcome
Maternal Hemoglobin Concentration
Time frame: Baseline, 28 weeks gestation, and 36-37 weeks gestation or at delivery
Maternal hemoglobin concentration measured using complete blood count (CBC) and compared between study groups.
1 secondary outcome
Birth Weight
Time frame: At birth
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 1 Jul 2026.
- Individual participant dataSharing planned: Undecided. At the time of study registration, no final decision has been made regarding the sharing of individual participant data (IPD). Any future data-sharing plan will be determined in accordance with institutional policies, ethical approvals, participant confidentiality requirements, and applicable regulatory requirements.
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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.
Rozina Feroz Ali, MBBS, MSC principal investigator
Sindh Institute of Child Health and Neonatology
Questions about this trial
What is this clinical trial studying?
A study testing Multiple Micronutrient Supplementation (MMS) and Iron-Folic Acid (IFA) in people with Maternal Anemia and Micronutrient Deficiency, run by Sindh Institute of Child Health and Neonatology.
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 6 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: opening soon, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Sher Wali Khan, MS (+923452860165, khansiut1@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal Hemoglobin Concentration (time frame: Baseline, 28 weeks gestation, and 36-37 weeks gestation or at delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2026.