Co-administration of Calcium and Multiple Micronutrient Supplements for Maternal and Newborn Hemoglobin and Iron Status
Key facts
- Who runs it
- Johns Hopkins Bloomberg School of Public Health
- Where
- Burkina Faso and Pakistan2 sites in 2 countriesChoose a country to see its sites
- Trial code
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 3,200 people, planned
- Started
- 25 Aug 2025
- Expected to end
- Apr 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Concurrent multiple micronutrient and calcium supplementation
- Separate multiple micronutrient and calcium supplementation
- Record updated
- 10 August 2026
Who can take part
- Age
- 15 years and older
- Sex
- Women only
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- Burkina Faso: married or unmarried pregnant women aged ≥15 years
- Pakistan: married pregnant women ≥18 years
- Willing to receive all antenatal care at a study clinic
- Willing to stop iron folic acid supplementation to receive the study intervention
- Hb ≥70 g/L
- 6<20 weeks of gestation based on fetal ultrasound
Who cannot take part
- Hemoglobin < 70 g/L
- Burkina Faso: <15 years or unmarried pregnant women <18 years without consent from parent / guardian
- Pakistan: pregnant women <18 years
- Unwilling to receive antenatal care at a study clinic
- Unwilling to stop iron folic acid supplementation to receive the study intervention
- <6 weeks of gestation or ≥20 weeks of gestation
- Non-viable or extrauterine pregnancy
- Any contraindications to study supplements
This trial has no sites in United States.
It has sites in 2 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
The World Health Organization (WHO) currently recommends the pregnant women receive iron-containing supplements and, in settings where calcium intake is low, calcium supplements. Supplements are to be taken at two separate times of the day as calcium may interfere with iron absorption. The goal of this clinical trial is to learn whether taking daily calcium supplements and iron-containing multiple micronutrient supplements together, at the same time, has any negative impact on the hemoglobin or iron status of pregnant women or the woman's infants. Participants will be randomly assigned and counseled to either take the supplements together every morning or to take the multiple micronutrient supplement in the morning and the calcium supplement in the evening. Participants will visit the antenatal clinic monthly and be asked to provide a blood sample in early, mid, and late pregnancy. Researchers will also take blood samples from infants at the time of birth.
The 2 groups in the trial
- Concurrent MMS / CalciumTreatment being tested
Daily multiple micronutrient supplement (providing 30 mg iron) taken concurrently with daily calcium supplement (500 mg)
Treatment: Concurrent multiple micronutrient and calcium supplementation
- Separate MMS / CalciumExisting treatment, for comparison
Daily multiple micronutrient supplement (providing 30 mg iron) taken separately from daily calcium supplement (500 mg)
Treatment: Separate multiple micronutrient and calcium supplementation
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Co-administration of Calcium and Multiple Micronutrient Supplements for Maternal and Newborn Hemoglobin and Iron Status: A Randomized Non-inferiority Trial in Burkina Faso and Pakistan
- Record updated
- 10 August 2026