Effects of multiple micronutrient supplements (MMS) versus iron folic acid (IFA) supplements on maternal and birth outcome: a controlled trial in Karachi, Pakistan
| ISRCTN | ISRCTN11392051 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11392051 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Baqai Medical University |
| Funder | Investigator initiated and funded |
- Submission date
- 03/11/2025
- Registration date
- 04/11/2025
- Last edited
- 04/11/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Anemia during pregnancy—especially when caused by low iron levels—is a serious health issue in Pakistan. It can affect a woman’s physical strength, energy, and ability to make decisions, and may even increase her risk of experiencing domestic violence. This study aims to find out whether taking iron and folic acid supplements or a mix of different vitamins and minerals is more effective in improving the health of pregnant women and their babies. It also looks at how these supplements might affect women’s empowerment and whether anemia is linked to domestic violence.
Who can participate?
Pregnant women in their first trimester (less than 14 weeks along) will be invited to take part in the study.
What does the study involve?
A total of 508 women will be recruited. Half will receive iron and folic acid supplements, and the other half will receive multiple micronutrient supplements. Participants will be asked to complete questionnaires about their background, experiences with domestic violence, and feelings of empowerment. Their blood will be tested for hemoglobin levels early in pregnancy and again in the third trimester. Information about their babies’ health will be collected after birth.
What are the possible benefits and risks of participating?
Participants may benefit from improved health during pregnancy and better outcomes for their babies. The study could also help raise awareness about the importance of nutrition and women’s empowerment. Risks are expected to be minimal, but may include discomfort from blood tests or sensitive questions in the surveys.
Where is the study run from?
Baqai Medical University in Pakistan.
When is the study starting and how long is it expected to run for?
September 2025 to December 2026.
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Shagufta Naseer, shaguftanaseer@gmail.com
Contact information
Public, Scientific, Principal investigator
Baqai Medical University
Karachi
75340
Pakistan
 ORCID ID |
0000-0002-2861-8924 |
|---|---|
| Phone | +92 3362147956 |
| shaguftanaseer@gmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multi center inferiority interventional randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Effects of multiple micronutrient supplements (MMS) versus iron folic acid (IFA) supplements on maternal and birth outcome: a controlled trial in Karachi, Pakistan |
| Study objectives | Primary Objectives: 1. To compare the frequency of maternal iron deficiency anemia among women receiving Iron Folic Acid (IFA) versus Multiple Micronutrient Supplement (Multiple Micronutrient Supplement) initiated in the first trimester (<14 weeks of gestation) 2. To compare the incidence of preterm birth, low birth weight and early neo-natal mortality between IFA and Multiple Micronutrient Supplement group initiated in the first trimester (<14 weeks of gestation) in a few hospitals of Karachi. Secondary Objectives: 1. To determine the association between iron deficiency anemia, domestic violence and women’s empowerment status. 2. To investigate how domestic violence and women’s empowerment status affect compliance with Iron and Folic Acid (IFA) or Multiple Micronutrient Supplementation (MMS) and their subsequent effects on pregnancy and neonatal outcomes i.e. preterm birth, low birth weight and early neo natal mortality. |
| Ethics approval(s) |
Approved 25/08/2025, Baqai Medical University (51, Deh Tor, Gadap Road, Super Highway, Karachi, 75340, Pakistan; +92 330 8180823; registrar.secretriat@baqai.edu.pk), ref: BMU-IREB/16-2025/002 |
| Health condition(s) or problem(s) studied | Anemia, low birth weight baby, early neo natal mortality |
| Intervention | IFA: In this interventional arm, women will be provided with Iron and Folic Acid (IFA) supplementation with a daily dose containing elemental iron of 60 milligrams and folic acid of 400 micrograms. MMS: In this interventional arm, women will be provided with United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP). The UNIMMAP Multiple Micronutrient Supplement formula contains 15 essential vitamins and minerals. Each tablet provides 30 mg of iron (as ferrous sulfate), 400 mcg of folic acid, and other key micronutrients, including 800 mcg of vitamin A, 70 mg of vitamin C, 200 IU of vitamin D, 10 mg of vitamin E, 1.5 mg of vitamin B1, 1.5 mg of vitamin B2, 18 mg of vitamin B3, 1.9 mg of vitamin B6, 2.6 mcg of vitamin B12, 150 mcg of iodine, 15 mg of zinc as zinc sulfate, 65 mcg of selenium, and 2 mg of copper (as copper sulfate). Participants will be systematically randomly assigned using a computer generated sequence of numbers corresponding to the total sample size. Participants with an odd number will be assigned to the MMS group, while those with even will be assigned to the IFA group. This approach ensures impartiality and provides each participant an equal chance of being placed in either group thereby reducing bias and ensuring comparability between groups. Criteria for discontinuation or modifying allocated intervention: Enrolled participants who report any adverse events in either intervention arm will be referred to their doctor for guidance and to obtain permission regarding whether to continue or withdraw from the intervention. In case of any adverse event due to the intervention, the medical management will be arranged by the researcher. As per the consent, participants retain the full right to withdraw from the research study at any point, for any reason, without experiencing any negative consequences or penalties. |
| Intervention type | Supplement |
| Primary outcome measure(s) |
1. Height is measured using a stadiometer at baseline |
| Key secondary outcome measure(s) |
1. Domestic violence experience is measured using a structured questionnaire at baseline |
| Completion date | 31/12/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 45 Years |
| Sex | Female |
| Target sample size at registration | 508 |
| Key inclusion criteria | 1. Pregnant women with gestational week less than 14 weeks 2. Low risk pregnancy and absence of any other medical and surgical complications 3. Pregnant women who are not planning to move out of the city within next 10 months 4. Not participating in any other research or nutritional program 5. Give consent to participate in this study |
| Key exclusion criteria | 1. Those with any pre-existing medical and surgical complications 2. Severe anemia (hemoglobin level < 7g/dL) 3. Those with any known mental illness |
| Date of first enrolment | 30/11/2025 |
| Date of final enrolment | 30/03/2026 |
Locations
Countries of recruitment
- Pakistan
Study participating centres
Karachi
75850
Pakistan
Karachi
75900
Pakistan
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The dataset analysed during the current study will be available on request from Dr Shagufta Naseer at shaguftanaseer@gmail.com |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
04/11/2025: Trial's existence confirmed by Baqai Medical University.
