Actively Recruiting

Phase 3
Age: 15Years +
FEMALE
Healthy Volunteers
NCT06568315

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

Led by Johns Hopkins Bloomberg School of Public Health · Updated on 2025-09-17

3200

Participants Needed

2

Research Sites

48 weeks

Total Duration

On this page

Sponsors

J

Johns Hopkins Bloomberg School of Public Health

Lead Sponsor

I

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

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 15Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant women in Burkina Faso aged 15 years or older, married or unmarried
  • Pregnant married women in Pakistan aged 18 years or older
  • Willing to receive all antenatal care at a study clinic
  • Willing to stop iron folic acid supplements to take the study supplements
  • Hemoglobin measurement of 70 g/L or higher
  • Pregnancy between greater than 6 weeks and less than 20 weeks by fetal ultrasound
Not Eligible

You will not qualify if you...

  • Pregnant women in Burkina Faso younger than 15 years or unmarried pregnant women younger than 18 years without parental or guardian consent
  • Pregnant women in Pakistan younger than 18 years
  • Unwilling to receive antenatal care at a study clinic
  • Unwilling to stop iron folic acid supplements to take the study supplements
  • Hemoglobin less than 70 g/L
  • Pregnancy less than 6 weeks or 20 weeks or more
  • Non-viable or ectopic pregnancy
  • Any medical conditions that make study supplements unsafe

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

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

Ouagadougou, Burkina Faso

Actively Recruiting

2

Aga Khan University

Karachi, Pakistan

Actively Recruiting

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Research Team

A

Amanda C Palmer, PhD

CONTACT

M

Monica Pasqualino, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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