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

NCT06568315 | Recruiting Phase 3 DMC

• 3 other identifiers: IRB00030029INV0366631911-04269
• Study Type: interventional
• Target: 3,200
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Anemia, Iron Deficiency

Keywords

calcium; iron; supplementation; anemia; pregnancy

Outcome Measures

Primary Outcomes (1)

• Hemoglobin concentration of pregnant women

  Hemoglobin measured by hematology analyzer

  30<34 weeks of gestation

Secondary Outcomes (12)

• Ferritin concentration

  30<34 weeks of gestation

• Soluble transferrin receptor (sTfR) concentration

  30<34 weeks of gestation

• Hepcidin concentration

  30<34 weeks of gestation

• Erythropoietin (EPO) concentration

  30<34 weeks of gestation

• sTfR-Ferritin index

  30<34 weeks of gestation

Other Outcomes (13)

• Proportion of women with anemia

  30<34 weeks of gestation

• Proportion of women with severe anemia (intervention safety)

  20<24 weeks or 30<34 weeks of gestation

• Proportion of women with iron deficiency

  30<34 weeks of gestation

Study Arms (2)

Concurrent MMS / Calcium

EXPERIMENTAL

Daily multiple micronutrient supplement (providing 30 mg iron) taken concurrently with daily calcium supplement (500 mg)

Dietary Supplement: Concurrent multiple micronutrient and calcium supplementation

Separate MMS / Calcium

ACTIVE COMPARATOR

Daily multiple micronutrient supplement (providing 30 mg iron) taken separately from daily calcium supplement (500 mg)

Dietary Supplement: Separate multiple micronutrient and calcium supplementation

Interventions

Concurrent multiple micronutrient and calcium supplementation DIETARY_SUPPLEMENT

Participants counseled to take United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP) multiple micronutrient supplement providing 30 mg elemental iron and calcium supplement providing 500 mg elemental calcium as 1250 mg calcium carbonate together every morning from enrollment through the end of pregnancy

Concurrent MMS / Calcium

Separate multiple micronutrient and calcium supplementation DIETARY_SUPPLEMENT

Participants counseled to take United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP) multiple micronutrient supplement (MMS) providing 30 mg elemental iron every morning and calcium supplement providing 500 mg elemental calcium as 1250 mg calcium carbonate every evening from enrollment through the end of pregnancy

Separate MMS / Calcium

Eligibility Criteria

• Age: 15 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• \<20 weeks of gestation based on fetal ultrasound

You may not qualify if:

• 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
• Hemoglobin \< 70 g/L
• \<6 weeks of gestation or ≥20 weeks of gestation
• Non-viable or extrauterine pregnancy
• Any contraindications to study supplements

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• 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

Study Sites (2)

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

Ouagadougou, Burkina Faso

RECRUITING

Aga Khan University

Karachi, Pakistan

RECRUITING

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Anemia

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Amanda Palmer, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda C Palmer, PhD

CONTACT

1 (410) 955-2061; acpalmer@jhu.edu

Monica Pasqualino, PhD

CONTACT

mpasqua2@jhmi.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Counseling messages and supplement packaging do not enable masking of participants or study staff with direct participant contact. Laboratory staff measuring the trial's outcomes and investigators will be masked.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 23, 2024
• Study Start: August 25, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD will be available after publication of the trial's outcomes
• Access Criteria: To be agreed upon with investigators

Locations

PA (1); BU (1)