Pregnancy RelatedPhase 3MID-ACTNCT06069869

Multiple Micronutrient Supplementation (MMS) Iron Dose Acceptability Crossover Trial

A Phase 3 study testing Multiple Micronutrient Supplements with 30 mg of elemental iron, Multiple Micronutrient Supplements with 45 mg of elemental iron and Multiple Micronutrient Supplements with 60 mg of elemental iron in people with Pregnancy Related, run by George Washington University at 1 site in Tanzania.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

This is an individually randomized cross-over trial to assess acceptability, preference, and perceived side effects of MMS formulations with 30 mg, 45 mg and 60 mg of iron. Read more about this study

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Pregnancy Related
What is being tested?: Multiple Micronutrient Supplements with 30 mg of elemental iron, Multiple Micronutrient Supplements with 45 mg of elemental iron and Multiple Micronutrient Supplements with 60 mg of elemental iron
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 156 participants
Where: 1 siteTanzania
Study dates: 26 Sep 2025to 24 Jun 2026
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Attending first ANC visit at the study clinic
Pregnant women ≤ 15 weeks of gestation
Aged ≥ 18 years
Intending to stay in Dar es Salaam for the duration of study
Provides informed consent

Who cannot join

Severe anemia (defined as Hb <8.5 g/dL per Tanzania standard of care)
Sickle cell disease (SS,SC, CC genotype) as tested by HemoTypeSC
Concurrent participation in other nutritional supplementation trial
Pregnant women with disability or condition which would impair their ability to provide informed consent and complete study procedures.

Trial locations and contacts

1 site in 1 country.

Tanzania1 site

Muhimbili University of Health and Allied Sciences
Dar es Salaam

Other trials in Tanzania

About this study

Official title: Individually Randomized Crossover Trial of Multiple Micronutrient Supplementation (MMS) Iron Dosages During Pregnancy in Tanzania

This is an individually randomized cross-over trial to assess acceptability, preference, and perceived side effects of MMS formulations with 30 mg, 45 mg and 60 mg of iron.

Conditions: Pregnancy Related
Being tested: Multiple Micronutrient Supplements with 30 mg of elemental iron, Multiple Micronutrient Supplements with 45 mg of elemental iron, Multiple Micronutrient Supplements with 60 mg of elemental iron
Keywords: Acceptability, Multiple Micronutrient Supplementation, Iron, Tanzania

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Multiple Micronutrient Supplements with 30 mg of elemental ironDietary supplement
MMS with 30 mg iron is the active comparator group. The standard UNIMMAP MMS formulation includes 30 mg of iron which will be taken orally once daily for one month.
Multiple Micronutrient Supplements with 45 mg of elemental ironDietary supplement
MMS with 45 mg iron is an intervention group. MMS with 45 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients will be taken orally once daily for one month.
Multiple Micronutrient Supplements with 60 mg of elemental ironDietary supplement
MMS with 60 mg iron is an intervention group. MMS with 60 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients will be taken orally once daily for one month.

Study groups in NCT06069869
Study group	Role	What they receive
MM 30mg; then MMS 45mg; then MMS 60mg	Experimental	Participants first receive MMS with 30 mg for one month, then MMS with 45 mg of iron for one month, then MMS with 60 mg of iron for one month Receives: Dietary Supplement: Multiple Micronutrient Supplements with 30 mg of elemental iron; Dietary Supplement: Multiple Micronutrient Supplements with 45 mg of elemental iron; Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental iron
MM 30mg; then MMS 60mg; then MMS 45mg	Experimental	Participants first receive MMS with 30mg for one month, then MMS with 60mg of iron for one month, then MMS with 45 mg of iron for one month Receives: Dietary Supplement: Multiple Micronutrient Supplements with 30 mg of elemental iron; Dietary Supplement: Multiple Micronutrient Supplements with 45 mg of elemental iron; Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental iron
MM 45mg; then MMS 30mg; then MMS 60mg	Experimental	Participants first receive MMS with 45 mg for one month, then MMS with 30 mg of iron for one month, then MMS with 60 mg of iron for one month Receives: Dietary Supplement: Multiple Micronutrient Supplements with 30 mg of elemental iron; Dietary Supplement: Multiple Micronutrient Supplements with 45 mg of elemental iron; Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental iron
MM 45 mg; then MMS 60mg; then MMS 30mg	Experimental	Participants first receive MMS with 45 mg for one month, then MMS with 60 mg of iron for one month, then MMS with 30 mg of iron for one month Receives: Dietary Supplement: Multiple Micronutrient Supplements with 30 mg of elemental iron; Dietary Supplement: Multiple Micronutrient Supplements with 45 mg of elemental iron; Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental iron
MM 60mg; then MMS 30mg; then MMS 45mg	Experimental	Participants first receive MMS with 60 mg for one month, then MMS with 30 mg of iron for one month, then MMS with 45 mg of iron for one month Receives: Dietary Supplement: Multiple Micronutrient Supplements with 30 mg of elemental iron; Dietary Supplement: Multiple Micronutrient Supplements with 45 mg of elemental iron; Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental iron
MM 60mg; then MMS 45mg; then MMS 30mg	Experimental	Participants first receive MMS with 60 mg for one month, then MMS with 45 mg of iron for one month, then MMS with 30 mg of iron for one month Receives: Dietary Supplement: Multiple Micronutrient Supplements with 30 mg of elemental iron; Dietary Supplement: Multiple Micronutrient Supplements with 45 mg of elemental iron; Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental iron

What is being measured

The primary outcome is the main question the study is designed to answer.

Acceptability of MMS formulations
Participant reported acceptability of each MMS formulation using Likert scales ranging from 1 (disliked a lot) to 5 (liked a lot).
Measured: At one month of taking each regimen, up to 3 months

Secondary outcomes (5)

Most preferred MMS formulation
Participant's reported preference for MMS formulations with 30 mg, 45 mg, or 60 mg of iron by asking which supplement participant likes the best.
Measured: At three months (after taking all three regimens)
Least preferred MMS formulation
Participant's reported preference for MMS formulations with 30 mg, 45 mg, or 60 mg of iron by asking which supplement participant likes the least.
Measured: At three months (after taking all three regimens)
Identification of MMS iron dosage
Percentage of participants that correctly identify their iron dose treatment order
Measured: At three months (after taking all three regimens)
Side effects of MMS formulations
The percentage of patients experiencing any side effect (diarrhea, heartburn, constipation, vomiting, nausea, leg cramps, lower back/pelvic pain) during each intervention period
Measured: At one month of taking each regimen, up to 3 months
Adherence
The percentage of days a participant takes a MMS pill out of the total number of days in the intervention period
Measured: At one month of taking each regimen, up to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Sep 202524 Jun 2026

First posted6 Oct 2023
Study start26 Sep 2025
Primary completion24 Jun 2026 (estimated)
Study completion24 Jun 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Model description: Each participant will be randomized to one of 6 sequence orders to receive the three MMS regimens first, second or third in order (e.g., 30, 45, then 60 mg; or 45, 30, then 60 mg; or 45, 60 then 30 mg etc.).
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 156 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06069869
Sponsor's protocol ID: MID-ACT
Acronym: MID-ACT
Status last verified: May 2026
First submitted: 15 Sep 2023
Last updated: 8 May 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: deidentified analytical dataset supporting published research

Publications

Sudfeld CR, Muhihi A, Sylvetsky AC, Metta E, Brownlee VS, Oakley EM, Bakari M, Fawzi WW, Kinyogoli S, Kuiper JR, Mugusi S, Pan Q, Sando MM, Wylie BJ, Masanja H, Smith ER, Pembe AB. Effect of iron dose in maternal multiple micronutrient supplement on perceived side effects, adherence, acceptability and preferences: protocol for a randomised crossover trial. BMJ Open. 2026 May 27;16(5):e118725. doi: 10.1136/bmjopen-2026-118725.
PubMed 42203269

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Association Between Polycystic Ovary Syndrome and Sleep Quality: A Questionnaire-Based Study
Sleep Disorder, Polycystic Ovarian Syndrome (PCOS)
Recruiting
PTSD Screening in Pregnant Black Women
Pregnancy Early, PTSD
Not yet recruiting
Effects of Ashwagandha Supplementation on Quality of Life and Well-Being in Women With Endometriosis
Endometriosis, Quality of Life
Recruiting
Trigeminal Nerve Stimulation for Children With Prenatal Alcohol Exposure
Fetal Alcohol Spectrum Disorders, Attention Deficit Hyperactivity Disorder
Not yet recruitingObservational study
Microbiota Changes Related to Outcomes in Kidney Transplantation
End-stage Renal Disease (ESRD), Kidney Transplantation

All Pregnancy Related trials

Study at a glance

From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Individually Randomized Crossover Trial of Multiple Micronutrient Supplementation (MMS) Iron Dosages During Pregnancy in Tanzania
ClinicalTrials.gov ID: NCT06069869
Acronym / sponsor ID: MID-ACT / MID-ACT
Conditions: Pregnancy Related
Keywords: Acceptability, Multiple Micronutrient Supplementation, Iron, Tanzania
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 156 participants (estimated)
Lead sponsor: George Washington UniversityUniversity, hospital or other
Collaborators: Ifakara Health Institute, Harvard School of Public Health (HSPH), Muhimbili University of Health and Allied Sciences, Africa Academy for Public Health, Columbia University
Study start: 26 Sep 2025 (actual)
Primary completion: 24 Jun 2026 (estimated)
Study completion: 24 Jun 2026 (estimated)
First posted: 6 Oct 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is an individually randomized cross-over trial to assess acceptability, preference, and perceived side effects of MMS formulations with 30 mg, 45 mg and 60 mg of iron.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6
Model description: Each participant will be randomized to one of 6 sequence orders to receive the three MMS regimens first, second or third in order (e.g., 30, 45, then 60 mg; or 45, 30, then 60 mg; or 45, 60 then 30 mg etc.).

Arm	Type	Receives
MM 30mg; then MMS 45mg; then MMS 60mg	Experimental	Dietary Supplement: Multiple Micronutrient Supplements with 30 mg of elemental iron, Dietary Supplement: Multiple Micronutrient Supplements with 45 mg of elemental iron, Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental ironParticipants first receive MMS with 30 mg for one month, then MMS with 45 mg of iron for one month, then MMS with 60 mg of iron for one month
MM 30mg; then MMS 60mg; then MMS 45mg	Experimental	Dietary Supplement: Multiple Micronutrient Supplements with 30 mg of elemental iron, Dietary Supplement: Multiple Micronutrient Supplements with 45 mg of elemental iron, Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental ironParticipants first receive MMS with 30mg for one month, then MMS with 60mg of iron for one month, then MMS with 45 mg of iron for one month
MM 45mg; then MMS 30mg; then MMS 60mg	Experimental	Dietary Supplement: Multiple Micronutrient Supplements with 30 mg of elemental iron, Dietary Supplement: Multiple Micronutrient Supplements with 45 mg of elemental iron, Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental ironParticipants first receive MMS with 45 mg for one month, then MMS with 30 mg of iron for one month, then MMS with 60 mg of iron for one month
MM 45 mg; then MMS 60mg; then MMS 30mg	Experimental	Dietary Supplement: Multiple Micronutrient Supplements with 30 mg of elemental iron, Dietary Supplement: Multiple Micronutrient Supplements with 45 mg of elemental iron, Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental ironParticipants first receive MMS with 45 mg for one month, then MMS with 60 mg of iron for one month, then MMS with 30 mg of iron for one month
MM 60mg; then MMS 30mg; then MMS 45mg	Experimental	Dietary Supplement: Multiple Micronutrient Supplements with 30 mg of elemental iron, Dietary Supplement: Multiple Micronutrient Supplements with 45 mg of elemental iron, Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental ironParticipants first receive MMS with 60 mg for one month, then MMS with 30 mg of iron for one month, then MMS with 45 mg of iron for one month
MM 60mg; then MMS 45mg; then MMS 30mg	Experimental	Dietary Supplement: Multiple Micronutrient Supplements with 30 mg of elemental iron, Dietary Supplement: Multiple Micronutrient Supplements with 45 mg of elemental iron, Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental ironParticipants first receive MMS with 60 mg for one month, then MMS with 45 mg of iron for one month, then MMS with 30 mg of iron for one month

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Attending first ANC visit at the study clinic
Pregnant women ≤ 15 weeks of gestation
Aged ≥ 18 years
Intending to stay in Dar es Salaam for the duration of study
Provides informed consent

Key exclusion criteria (4 listed)

Severe anemia (defined as Hb <8.5 g/dL per Tanzania standard of care)
Sickle cell disease (SS,SC, CC genotype) as tested by HemoTypeSC
Concurrent participation in other nutritional supplementation trial
Pregnant women with disability or condition which would impair their ability to provide informed consent and complete study procedures.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Multiple Micronutrient Supplements with 30 mg of elemental ironMMS with 30 mg iron is the active comparator group. The standard UNIMMAP MMS formulation includes 30 mg of iron which will be taken orally once daily for one month.	Dietary supplement	MM 30mg; then MMS 45mg; then MMS 60mg, MM 30mg; then MMS 60mg; then MMS 45mg, MM 45 mg; then MMS 60mg; then MMS 30mg, MM 45mg; then MMS 30mg; then MMS 60mg, MM 60mg; then MMS 30mg; then MMS 45mg, MM 60mg; then MMS 45mg; then MMS 30mg
Multiple Micronutrient Supplements with 45 mg of elemental ironMMS with 45 mg iron is an intervention group. MMS with 45 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients will be taken orally once daily for one month.	Dietary supplement	MM 30mg; then MMS 45mg; then MMS 60mg, MM 30mg; then MMS 60mg; then MMS 45mg, MM 45 mg; then MMS 60mg; then MMS 30mg, MM 45mg; then MMS 30mg; then MMS 60mg, MM 60mg; then MMS 30mg; then MMS 45mg, MM 60mg; then MMS 45mg; then MMS 30mg
Multiple Micronutrient Supplements with 60 mg of elemental ironMMS with 60 mg iron is an intervention group. MMS with 60 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients will be taken orally once daily for one month.	Dietary supplement	MM 30mg; then MMS 45mg; then MMS 60mg, MM 30mg; then MMS 60mg; then MMS 45mg, MM 45 mg; then MMS 60mg; then MMS 30mg, MM 45mg; then MMS 30mg; then MMS 60mg, MM 60mg; then MMS 30mg; then MMS 45mg, MM 60mg; then MMS 45mg; then MMS 30mg

Primary outcome

Acceptability of MMS formulations
Time frame: At one month of taking each regimen, up to 3 months
Participant reported acceptability of each MMS formulation using Likert scales ranging from 1 (disliked a lot) to 5 (liked a lot).

5 secondary outcomes

Most preferred MMS formulation
Time frame: At three months (after taking all three regimens)
Least preferred MMS formulation
Time frame: At three months (after taking all three regimens)
Identification of MMS iron dosage
Time frame: At three months (after taking all three regimens)
Side effects of MMS formulations
Time frame: At one month of taking each regimen, up to 3 months
Adherence
Time frame: At one month of taking each regimen, up to 3 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
Derived from this study: PubMed 42203269Sudfeld CR, Muhihi A, Sylvetsky AC, Metta E, Brownlee VS, Oakley EM, Bakari M, Fawzi WW, Kinyogoli S, Kuiper JR, Mugusi S, Pan Q, Sando MM, Wylie BJ, Masanja H, Smith ER, Pembe AB. Effect of iron dose in maternal multiple micronutrient supplement on perceived side effects, adherence, acceptability and preferences: protocol for a randomised crossover trial. BMJ Open. 2026 May 27;16(5):e118725. doi: 10.1136/bmjopen-2026-118725.
Individual participant dataSharing planned: Yes. deidentified analytical dataset supporting published research

Related trials for Pregnancy Related

Active, not recruitingObservational study
Association Between Polycystic Ovary Syndrome and Sleep Quality: A Questionnaire-Based Study
Sleep Disorder, Polycystic Ovarian Syndrome (PCOS)
Recruiting
PTSD Screening in Pregnant Black Women
Pregnancy Early, PTSD
Not yet recruiting
Effects of Ashwagandha Supplementation on Quality of Life and Well-Being in Women With Endometriosis
Endometriosis, Quality of Life
Recruiting
Trigeminal Nerve Stimulation for Children With Prenatal Alcohol Exposure
Fetal Alcohol Spectrum Disorders, Attention Deficit Hyperactivity Disorder
Not yet recruitingObservational study
Microbiota Changes Related to Outcomes in Kidney Transplantation
End-stage Renal Disease (ESRD), Kidney Transplantation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Blair Wylie, MD, MPH principal investigator

Columbia University

Honorati Masanja, PhD principal investigator

Ifakara Health Institute

Alfa Muhihi, PhD principal investigator

Africa Academy for Public Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptability of MMS formulations (time frame: At one month of taking each regimen, up to 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06069869, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.