MalnutritionNCT06641349
Effect of Maternal Supplementation From Preconception to Lactation on Child Growth and Development
An observational study of Malnutrition and Growth &Amp; Development, run by University of Toronto at 1 site in Pakistan.
Trial summary
The goal of this observational study is to learn about the long-term effects of maternal multiple micronutrient supplementation from preconception through to lactation on child neurodevelopment and growth in a resource-limited setting where there is a high burden of malnutrition. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Malnutrition, Growth &Amp; Development
- Type of treatment
- Pill or oral medicine
- How many people
- 150 participants
- Where
- 1 sitePakistan
- Study dates
- 13 Jan 2025to 4 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Residence within Matiari District, Pakistan
Who may be able to join
- Child participated in the MaPPS Trial Breastmilk Sub-study at 3-months of age
- Child has reached their fourth birthday
- Child is available in the study catchment area (Matiari District)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Maternal Multiple Micronutrient Supplementation From Preconception Through Lactation on Child Growth and Development in Rural Pakistan: A Follow-up Study
The goal of this observational study is to learn about the long-term effects of maternal multiple micronutrient supplementation from preconception through to lactation on child neurodevelopment and growth in a resource-limited setting where there is a high burden of malnutrition. The main questions it aims to answer are:
- Does maternal multiple micronutrient supplementation from preconception through to lactation compared to the standard of care have an effect on child neurodevelopment?
- Does maternal multiple micronutrient supplementation from preconception through to lactation compared to the standard of care have an effect on child growth?
This is a cross-sectional follow up study to a substudy of breastmilk composition and infant growth within the Matiari emPowerment and Preconception Supplementation (MaPPS) Trial, wherein mothers were randomized to receive a multiple micronutrient supplement from preconception through to lactation or the standard of care (ClinicalTrials.gov Identifier: NCT04451395).
- Conditions
- Malnutrition, Growth &Amp; Development
- Keywords
- malnutrition, multiple micronutrient supplement, neurodevelopment, growth
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children born to mothers who received a multiple micronutrient supplement | From preconception to 6-months postpartum, mothers received a multiple micronutrient supplement (oral tablet at UNIMMAP composition [30 mg iron, 400 μg folic acid, 15 mg zinc, 2 mg copper, 65 μg selenium, 800 μg RE vitamin A, 1.4 mg vitamin B1, 1.4 mg vitamin B2, 18 mg niacin, 1.9 mg vitamin B6, 2.6 μg vitamin B12, 70 mg vitamin C, 5 μg vitamin D, 10 mg vitamin E and 150 μg iodine]) | |
| Children born to mothers who received the standard of care | From preconception to 6-months postpartum, mothers received the standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Full scale IQ score
Wechsler Preschool and Primary Scale of Intelligence (WPPSI), minimum score: 40 and maximum score: 160 (higher scores mean a better outcome)
Measured: At 4 years of age
Secondary outcomes (3)
Fine and gross motor skills score
Bruininks-Oseretsky Test of Motor Proficiency, 2nd edition (BOT-2) Brief Form, minimum score: 0 and maximum score: 80 (higher scores mean a better outcome)
Measured: At 4 years of age
Height
Measured: At 4 years of age
Head circumference
Measured: At 4 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start13 Jan 2025
- Primary completion4 Jun 2025
- Study completion4 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Aga Khan University
- Responsible party
- Principal investigator, Deborah O'Connor, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06641349
- Sponsor's protocol ID
- 46670
- Status last verified
- Aug 2025
- First submitted
- 11 Oct 2024
- Last updated
- 21 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Maternal Multiple Micronutrient Supplementation From Preconception Through Lactation on Child Growth and Development in Rural Pakistan: A Follow-up Study
- ClinicalTrials.gov ID
- NCT06641349
- Acronym / sponsor ID
- 46670
- Conditions
- Malnutrition, Growth &Amp; Development
- Keywords
- malnutrition, multiple micronutrient supplement, neurodevelopment, growth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Aga Khan University
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- 4 Jun 2025 (actual)
- Study completion
- 4 Jun 2025 (actual)
- First posted
- 15 Oct 2024 (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.
The goal of this observational study is to learn about the long-term effects of maternal multiple micronutrient supplementation from preconception through to lactation on child neurodevelopment and growth in a resource-limited setting where there is a high burden of malnutrition. The main questions it aims to answer are:
- Does maternal multiple micronutrient supplementation from preconception through to lactation compared to the standard of care have an effect on child neurodevelopment?
- Does maternal multiple micronutrient supplementation from preconception through to lactation compared to the standard of care have an effect on child growth?
This is a cross-sectional follow up study to a substudy of breastmilk composition and infant growth within the Matiari emPowerment and Preconception Supplementation (MaPPS) Trial, wherein mothers were randomized to receive a multiple micronutrient supplement from preconception through to lactation or the standard of care (ClinicalTrials.gov Identifier: NCT04451395).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children born to mothers who received a multiple micronutrient supplement | – | –From preconception to 6-months postpartum, mothers received a multiple micronutrient supplement (oral tablet at UNIMMAP composition [30 mg iron, 400 μg folic acid, 15 mg zinc, 2 mg copper, 65 μg selenium, 800 μg RE vitamin A, 1.4 mg vitamin B1, 1.4 mg vitamin B2, 18 mg niacin, 1.9 mg vitamin B6, 2.6 μg vitamin B12, 70 mg vitamin C, 5 μg vitamin D, 10 mg vitamin E and 150 μg iodine]) |
| Children born to mothers who received the standard of care | – | –From preconception to 6-months postpartum, mothers received the standard of care |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Residence within Matiari District, Pakistan
Key inclusion criteria (3 listed)
- Child participated in the MaPPS Trial Breastmilk Sub-study at 3-months of age
- Child has reached their fourth birthday
- Child is available in the study catchment area (Matiari District)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Full scale IQ score
Time frame: At 4 years of age
Wechsler Preschool and Primary Scale of Intelligence (WPPSI), minimum score: 40 and maximum score: 160 (higher scores mean a better outcome)
3 secondary outcomes
Fine and gross motor skills score
Time frame: At 4 years of age
Height
Time frame: At 4 years of age
Head circumference
Time frame: At 4 years of age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition and Growth &Amp; Development, run by University of Toronto at 1 site in Pakistan.
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 3 inclusion and 0 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: finished, as of the sponsor's last update on 21 Aug 2025. 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 Pakistan. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Full scale IQ score (time frame: At 4 years of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2025.