Co-administration of Calcium and Multiple Micronutrient Supplements for Maternal and Newborn Hemoglobin and Iron Status

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age15+
SponsorJohns Hopkins Bloomberg School of Public Health

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Concurrent multiple micronutrient and calcium supplementation
  • Separate multiple micronutrient and calcium supplementation

Treatment groups

3,200 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Johns Hopkins Bloomberg School of Public Health

Lead sponsor

Institut Africain de Santé Publique (African Institute of Public Health)

Collaborator

Aga Khan University

Collaborator

Bill and Melinda Gates Foundation

Collaborator

Children's Investment Fund Foundation

Collaborator