Breast Milk CollectionNCT04451395
Investigating Pathways Between Maternal Nutritional Status, Breastmilk Composition, and Infant Linear Growth in Rural Pakistan
A study testing Multiple micronutrients (UNIMMAP composition) in people with Breast Milk Collection and Infant Development, run by Aga Khan University at 1 site in Pakistan.
Trial summary
Breastmilk is considered optimal for infant growth and development. However, evidence suggests that breastmilk composition can vary according to maternal nutritional status. Among women in Pakistan, there is a high burden of undernutrition and micronutrient deficiencies. Read more about this study
- Who is it for?
- Ages 15 to 25 years, women only
- Conditions the study is for
- Breast Milk Collection, Infant Development
- What is being tested?
- Multiple micronutrients (UNIMMAP composition)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Aug 2020to 31 Mar 2021
- Phase
- Interventional
- 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 15 to 25 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Enrolled in the MaPPS Trial
- Mothers must report practicing exclusive or predominant breastfeeding (i.e., breastmilk only or breastmilk and non-nutritive feeds only)
- The infant must be term-born (>37 weeks gestation)
- Infant must be 3 months ± 30 days old at the time of recruitment
- Mothers must be willing to provide a complete breastmilk expression from one breast
- Intervention arm only: mother reports compliance with study-administered MMN supplements at least 50% of the time (i.e., 4 out of 7 days per week)
- Able to provide informed consent
Who cannot join
- Mother reports mixed feeding in her infant with nutritive feeds (i.e., any provision of formula or animal milk)
- The infant was born preterm (earlier than 37 weeks gestation)
- Mother does not wish to provide a complete breast expression of one breast
- Intervention arm: mother reports compliance with MMN supplements <50% of the time
Trial locations and contacts
1 site in 1 country.
About this study
Breastmilk is considered optimal for infant growth and development. However, evidence suggests that breastmilk composition can vary according to maternal nutritional status. Among women in Pakistan, there is a high burden of undernutrition and micronutrient deficiencies. As well, the prevalence of early stunting among Pakistani infants is high. Using a hypothesized pathway model, this study will assess pathways between maternal nutritional status, breastmilk composition, and infant linear growth. This is a substudy to the Matiari emPowerment and Preconception Supplementation (MaPPS) Trial (ClinicalTrials.gov Identifier: NCT03287882).
- Conditions
- Breast Milk Collection, Infant Development
- Being tested
- Multiple micronutrients (UNIMMAP composition)
- Medical subject headings
- Breast Milk Expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple micronutrients (UNIMMAP composition)Dietary supplement
The intervention is an oral tablet containing 15 different vitamins and minerals at the UNIMMAP composition (includes 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). Each tablet is small (approximately 10 mm diameter) and has been procured using the UNICEF supply catalogue. A single MMN supplementation dose will consist of a single tablet.
Other Name: UNICEF, Micronutrient tabs, pregnancy/PAC-1000
| Study group | Role | What they receive |
|---|---|---|
| Multiple micronutrients (UNIMMAP composition) | Experimental | The intervention is an oral tablet containing 15 different vitamins and minerals at the UNIMMAP composition (includes 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). Each tablet is small (approximately 10 mm diameter) and has been procured using the UNICEF supply catalogue. A single MMN supplementation dose will consist of a single tablet..The supplement is provided within the parent trial.
Other Name: UNICEF, Micronutrient tabs, pregnancy/PAC-1000 Receives: Dietary Supplement: Multiple micronutrients (UNIMMAP composition) |
| Standard of care | No intervention | Daily iron and folic acid supplementation provided through the existing public health system. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal BMI
Measured: 3 months postpartum
Maternal dietary diversity score
Minimum score: 0, maximum score: 10
Measured: 3 months postpartum
Maternal hemoglobin concentration
Measured: 3 months postpartum
Maternal supplement adherence
Determined by report (options: 0, 25, 50, 75, or 100%)
Measured: 3 months postpartum
Breastmilk macronutrient composition
Measured: 3 months postpartum
Breastmilk micronutrient composition
Measured: 3 months postpartum
Infant length
Measured: 3 months postpartum
Secondary outcomes (6)
Infant weight
Measured: 3 months postpartum
Infant middle-upper arm circumference
Measured: 3 months postpartum
Infant head circumference
Measured: 3 months postpartum
Breastmilk bioactive composition
Measured: 3 months postpartum
Breastmilk microbiome
Measured: 3 months postpartum
Infant microbiome
Measured: 3 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start5 Aug 2020
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
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 Breast Milk CollectionStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- The Hospital for Sick Children, University of Toronto
- Responsible party
- Principal investigator, Dr Zulfiqar Ahmed Bhutta, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04451395
- Sponsor's protocol ID
- 2020-3676-10314
- Status last verified
- Jul 2021
- First submitted
- 22 Jun 2020
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Please contact the Primary Investigator directly for more details.
Publications
Baxter JB, Wasan Y, Daniel AI, Begum K, Hussain A, Iqbal J, Aufreiter S, Beggs MR, Duan L, Greco A, Huang C, Soofi S, Bandsma RH, Bhutta ZA, O'Connor DL. Maternal multiple micronutrient supplementation in rural Pakistan increased some milk micronutrient concentrations, but not infant growth, at three-months postpartum: a randomized controlled trial substudy. Am J Clin Nutr. 2025 Jul;122(1):174-184. doi: 10.1016/j.ajcnut.2025.05.019. Epub 2025 May 21.
PubMed 40409469
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Pathways Between Maternal Nutritional Status, Breastmilk Composition, and Infant Linear Growth in Rural Pakistan
- ClinicalTrials.gov ID
- NCT04451395
- Acronym / sponsor ID
- 2020-3676-10314
- Conditions
- Breast Milk Collection, Infant Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- The Hospital for Sick Children, University of Toronto
- Study start
- 5 Aug 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 30 Jun 2020 (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.
Breastmilk is considered optimal for infant growth and development. However, evidence suggests that breastmilk composition can vary according to maternal nutritional status. Among women in Pakistan, there is a high burden of undernutrition and micronutrient deficiencies. As well, the prevalence of early stunting among Pakistani infants is high. Using a hypothesized pathway model, this study will assess pathways between maternal nutritional status, breastmilk composition, and infant linear growth. This is a substudy to the Matiari emPowerment and Preconception Supplementation (MaPPS) Trial (ClinicalTrials.gov Identifier: NCT03287882).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multiple micronutrients (UNIMMAP composition) | Experimental | Dietary Supplement: Multiple micronutrients (UNIMMAP composition)The intervention is an oral tablet containing 15 different vitamins and minerals at the UNIMMAP composition (includes 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). Each tablet is small (approximately 10 mm diameter) and has been procured using the UNICEF supply catalogue. A single MMN supplementation dose will consist of a single tablet..The supplement is provided within the parent trial. Other Name: UNICEF, Micronutrient tabs, pregnancy/PAC-1000 |
| Standard of care | No intervention | –Daily iron and folic acid supplementation provided through the existing public health system. |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Enrolled in the MaPPS Trial
- Mothers must report practicing exclusive or predominant breastfeeding (i.e., breastmilk only or breastmilk and non-nutritive feeds only)
- The infant must be term-born (>37 weeks gestation)
- Infant must be 3 months ± 30 days old at the time of recruitment
- Mothers must be willing to provide a complete breastmilk expression from one breast
Key exclusion criteria (4 listed)
- Mother reports mixed feeding in her infant with nutritive feeds (i.e., any provision of formula or animal milk)
- The infant was born preterm (earlier than 37 weeks gestation)
- Mother does not wish to provide a complete breast expression of one breast
- Intervention arm: mother reports compliance with MMN supplements <50% of the time
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 micronutrients (UNIMMAP composition)The intervention is an oral tablet containing 15 different vitamins and minerals at the UNIMMAP composition (includes 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). Each tablet is small (approximately 10 mm diameter) and has been procured using the UNICEF supply catalogue. A single MMN supplementation dose will consist of a single tablet. Other Name: UNICEF, Micronutrient tabs, pregnancy/PAC-1000 | Dietary supplement | Multiple micronutrients (UNIMMAP composition) |
Primary outcome
Maternal BMI
Time frame: 3 months postpartum
Maternal dietary diversity score
Time frame: 3 months postpartum
Minimum score: 0, maximum score: 10
Maternal hemoglobin concentration
Time frame: 3 months postpartum
Maternal supplement adherence
Time frame: 3 months postpartum
Determined by report (options: 0, 25, 50, 75, or 100%)
Breastmilk macronutrient composition
Time frame: 3 months postpartum
Breastmilk micronutrient composition
Time frame: 3 months postpartum
Infant length
Time frame: 3 months postpartum
6 secondary outcomes
Infant weight
Time frame: 3 months postpartum
Infant middle-upper arm circumference
Time frame: 3 months postpartum
Infant head circumference
Time frame: 3 months postpartum
Breastmilk bioactive composition
Time frame: 3 months postpartum
Breastmilk microbiome
Time frame: 3 months postpartum
Infant microbiome
Time frame: 3 months postpartum
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 27 Jul 2021.
- Derived from this study: PubMed 40409469Baxter JB, Wasan Y, Daniel AI, Begum K, Hussain A, Iqbal J, Aufreiter S, Beggs MR, Duan L, Greco A, Huang C, Soofi S, Bandsma RH, Bhutta ZA, O'Connor DL. Maternal multiple micronutrient supplementation in rural Pakistan increased some milk micronutrient concentrations, but not infant growth, at three-months postpartum: a randomized controlled trial substudy. Am J Clin Nutr. 2025 Jul;122(1):174-184. doi: 10.1016/j.ajcnut.2025.05.019. Epub 2025 May 21.
- Individual participant dataSharing planned: Yes. Please contact the Primary Investigator directly for more details.
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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?
A study testing Multiple micronutrients (UNIMMAP composition) in people with Breast Milk Collection and Infant Development, run by Aga Khan University 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 7 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: finished, as of the sponsor's last update on 27 Jul 2021. 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?
Maternal BMI (time frame: 3 months postpartum). The study lists 7 primary outcomes in all. 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 NCT04451395, 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 27 Jul 2021.