PregnancyNCT07173881
Effect of a Dairy Product for Pregnant and Lactating Women on the Composition of Human Milk
A study testing Fortified powder milk in people with Pregnancy, run by Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri at 2 sites in Argentina.
Trial summary
Vulnerable populations, who have deficient diets, may produce human milk (HML) that is not adequate in all nutrients, and this will have consequences on the growth and development of the child. 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
- What is being tested?
- Fortified powder milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesArgentina
- Study dates
- 1 Aug 2025to 30 Jan 2026
- Phase
- Interventional
- 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
- Intervention group: Pregnant women over 18 years of age who undergo prenatal care during gestational weeks (GW) 28 ± 1 at the Maternal Nutrition Clinic of the H.I.G.A. "San Martín" in La Plata, and who regularly consume milk, will be included.
- Control group: Women over 18 years of age who attend their child's first checkup before the first month of life at the Maternal Clinic of the IDIP Health Observatory, and who exclusively breastfeed their children, will be included.
Who cannot join
- Women who have had multiple pregnancies and/or women with malabsorption diseases.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Argentina2 sites, 2 recruiting
- Recruiting
Hospital Interzonal de Agudos General San Martín
La Plata, Buenos Aires, 1900
Sofia A Rui, Bachelor degree nutrition, 5492281566075, sofiaarui@hotmail.com
- Recruiting
Instituto de Desarrollo e Investigaciones Pediátricas (IDIP) - HIAEP Sor María Ludovica
La Plata, Buenos Aires, 1900
Ignacio A Mendez, MS Nutrition, 01158671615, ignacioagustinmg@gmail.com
About this study
Official title: Effect of Consumption of a Dairy Product Designed for Pregnant and Lactating Women on the Composition of Human Milk. A Quasi-experimental Study in a Vulnerable Population
Vulnerable populations, who have deficient diets, may produce human milk (HML) that is not adequate in all nutrients, and this will have consequences on the growth and development of the child. In 2021, at IDIP, a specific milk product for pregnant and lactating women, Super Mil Mamá ( SMM, whole milk powder fortified with multiple vitamins, minerals, and DHA ) was designed and developed as part of a key strategy to incorporate into public policies for the first 1000 days of life. However, the potential benefits of this product have not yet been evaluated at the population level. The main objective is to evaluate the effect of the consumption of a milk product (SMM) designed for pregnant women on maternal nutritional status and the composition of human milk at one month postpartum.
Specific objectives include:
Read more
To compare the concentrations of DHA, Vitamins A, E, and D, Iron, Iodine, Zinc, and Calcium in human milk at one month postpartum of mothers who consumed SSM or not.
To compare the concentrations of DHA, Vitamins A, E, D and Zinc in blood and the nutritional status of maternal iron between mothers who consumed SSM and those who did not.
- Conditions
- Pregnancy
- Being tested
- Fortified powder milk
- Keywords
- human milk, vulnerable population, pregnancy, nutritional supplements, esencial fatty acids, micronutrients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fortified powder milkDietary supplement
Super 1.000 Mamá It's made up of milk with added vegetable oils, fish oil, carbohydrates from corn, prebiotic fiber (inulin), vitamins, and minerals, with specifically defined proportions. It has medium energy content, is balanced in protein, fats, and carbohydrates, and provides a significant content of both polyunsaturated fatty acids, such as omega-6, and omega-3, and the added docosahexaenoic acid, as recommended by international organizations. The reconstituted 200 ml serving delivers between 20 and 40% of the Daily Reference Intake in critical nutrients for this particular group of people, which include minerals such as calcium, iron, zinc, iodine, and vitamins such as A, D, C, B12 and folic acid. The rest of the vitamins, and minerals are also at the same level, allowing those who consume it to incorporate a large amount of nutrients regularly. Addvance SA, an SME dairy company from the Province of Santa Fe, will carry out the production of this milk.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Super 1.000 Mamá | Experimental | Pregnant women who will consume a fortified powdered dairy product formulated and designed specifically for this population during pregnancy and the first month postpartum. Receives: Dietary Supplement: Fortified powder milk |
| Sham Comparator: No milk consumption | No intervention | Breastfeeding women who have not consumed SMM until the first month postpartum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast milk DHA concentration
Description: concentration of DHA in breast milk expressed as a percentage of DHA with respect to the total fatty acids contained in the analyzed sample
Measured: Time Frame: breast milk DHA concentration will be assessed at one month postpartum.
Mother Zinc concentration
Zinc concentration in mother serum expressed in mg/dl
Measured: Mother Zinc concentration will be assessed at one month postpartum
mother Vit E concentration
α-tocopherol concentration in mother serum expressed in μmol/L
Measured: Mother's serum α-tocopherol concentration will be assessed at one month postpartum
Mother Vit A concentration
Retinol concentration in mother serum expressed in μmol/L
Measured: Mother's Vit A concentration will be assessed at one month postpartum
Mother red blood cell DHA concentration
Concentration of DHA in mother's red blood cell expressed as a percentage of DHA with respect to the total fatty acids contained in the analyzed sample
Measured: Mother's serum DHA concentration will be assessed at one month postpartum
Mother hemoglobin concentration
hemoglobin concentration in mother serum expressed in g/dL
Measured: Mother's hemoglobin concentration will be assessed one month postpartum
Breast milk Vitamin A concentration
Retinol concentration in breast milk expressed in μmol/L and μg/g fat contained in the analyzed sample
Measured: Breast milk Vitamin A concentration will be assessed at one month postpartum
Breast milk Vitamin E concentration
α-tocopherol concentration in breast milk expressed in μmol/L and μg/g fat contained in the analyzed sample
Measured: Breast milk Vitamin E concentration will be assessed at one month postpartum
Breast milk Vitamin D concentration
25-hidroxi vitamin D concentration in breast milk expressed in ng/ml
Measured: Breast milk Vitamin D concentration will be assessed at one month postpartum
Breast milk Zinc concentration
Zinc concentration in breast milk expressed in mg/dl
Measured: Breast milk Zinc concentration will be assessed at one month postpartum
Breast milk Calcium concentration
Calcium concentration in breast milk expressed in mg/dl
Measured: Breast milk Calcium concentration will be assessed at one month postpartum
Breast milk Iron concentration
Iron concentration in breast milk expressed in mg/dl
Measured: Breast milk Iron concentration will be assessed at one month postpartum
Breast milk Iodine concentration
Iodine concentration in breast milk expressed in mg/dl
Measured: Breast milk Iodine concentration will be assessed at one month postpartum
Mother serum ferritin concentration
ferritin concentration in mother serum expressed in ng/ml
Measured: Mother's serum ferritin concentration will be assessed at one month postpartum
mother Vit D concentration
25-hidroxi vitamin D concentration in mother serum expressed in ng/ml
Measured: mother Vit D concentration will be assessed at one month postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start1 Aug 2025
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Interzonal de Agudos General San Martín
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07173881
- Sponsor's protocol ID
- UCTH 2025
- Status last verified
- Aug 2025
- First submitted
- 8 Sep 2025
- Last updated
- 15 Sep 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 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Consumption of a Dairy Product Designed for Pregnant and Lactating Women on the Composition of Human Milk. A Quasi-experimental Study in a Vulnerable Population
- ClinicalTrials.gov ID
- NCT07173881
- Acronym / sponsor ID
- UCTH 2025
- Conditions
- Pregnancy
- Keywords
- human milk, vulnerable population, pregnancy, nutritional supplements, esencial fatty acids, micronutrients
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. ViteriUniversity, hospital or other
- Collaborators
- Hospital Interzonal de Agudos General San Martín
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 15 Sep 2025 (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.
Vulnerable populations, who have deficient diets, may produce human milk (HML) that is not adequate in all nutrients, and this will have consequences on the growth and development of the child. In 2021, at IDIP, a specific milk product for pregnant and lactating women, Super Mil Mamá ( SMM, whole milk powder fortified with multiple vitamins, minerals, and DHA ) was designed and developed as part of a key strategy to incorporate into public policies for the first 1000 days of life. However, the potential benefits of this product have not yet been evaluated at the population level. The main objective is to evaluate the effect of the consumption of a milk product (SMM) designed for pregnant women on maternal nutritional status and the composition of human milk at one month postpartum.
Specific objectives include:
To compare the concentrations of DHA, Vitamins A, E, and D, Iron, Iodine, Zinc, and Calcium in human milk at one month postpartum of mothers who consumed SSM or not.
To compare the concentrations of DHA, Vitamins A, E, D and Zinc in blood and the nutritional status of maternal iron between mothers who consumed SSM and those who did not.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Super 1.000 Mamá | Experimental | Dietary Supplement: Fortified powder milkPregnant women who will consume a fortified powdered dairy product formulated and designed specifically for this population during pregnancy and the first month postpartum. |
| Sham Comparator: No milk consumption | No intervention | –Breastfeeding women who have not consumed SMM until the first month postpartum |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Intervention group: Pregnant women over 18 years of age who undergo prenatal care during gestational weeks (GW) 28 ± 1 at the Maternal Nutrition Clinic of the H.I.G.A. "San Martín" in La Plata, and who regularly consume milk, will be included.
- Control group: Women over 18 years of age who attend their child's first checkup before the first month of life at the Maternal Clinic of the IDIP Health Observatory, and who exclusively breastfeed their children, will be included.
Key exclusion criteria (1 listed)
- Women who have had multiple pregnancies and/or women with malabsorption diseases.
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 |
|---|---|---|
| Fortified powder milkSuper 1.000 Mamá It's made up of milk with added vegetable oils, fish oil, carbohydrates from corn, prebiotic fiber (inulin), vitamins, and minerals, with specifically defined proportions. It has medium energy content, is balanced in protein, fats, and carbohydrates, and provides a significant content of both polyunsaturated fatty acids, such as omega-6, and omega-3, and the added docosahexaenoic acid, as recommended by international organizations. The reconstituted 200 ml serving delivers between 20 and 40% of the Daily Reference Intake in critical nutrients for this particular group of people, which include minerals such as calcium, iron, zinc, iodine, and vitamins such as A, D, C, B12 and folic acid. The rest of the vitamins, and minerals are also at the same level, allowing those who consume it to incorporate a large amount of nutrients regularly. Addvance SA, an SME dairy company from the Province of Santa Fe, will carry out the production of this milk. | Dietary supplement | Experimental: Super 1.000 Mamá |
Primary outcome
Breast milk DHA concentration
Time frame: Time Frame: breast milk DHA concentration will be assessed at one month postpartum.
Description: concentration of DHA in breast milk expressed as a percentage of DHA with respect to the total fatty acids contained in the analyzed sample
Mother Zinc concentration
Time frame: Mother Zinc concentration will be assessed at one month postpartum
Zinc concentration in mother serum expressed in mg/dl
mother Vit E concentration
Time frame: Mother's serum α-tocopherol concentration will be assessed at one month postpartum
α-tocopherol concentration in mother serum expressed in μmol/L
Mother Vit A concentration
Time frame: Mother's Vit A concentration will be assessed at one month postpartum
Retinol concentration in mother serum expressed in μmol/L
Mother red blood cell DHA concentration
Time frame: Mother's serum DHA concentration will be assessed at one month postpartum
Concentration of DHA in mother's red blood cell expressed as a percentage of DHA with respect to the total fatty acids contained in the analyzed sample
Mother hemoglobin concentration
Time frame: Mother's hemoglobin concentration will be assessed one month postpartum
hemoglobin concentration in mother serum expressed in g/dL
Breast milk Vitamin A concentration
Time frame: Breast milk Vitamin A concentration will be assessed at one month postpartum
Retinol concentration in breast milk expressed in μmol/L and μg/g fat contained in the analyzed sample
Breast milk Vitamin E concentration
Time frame: Breast milk Vitamin E concentration will be assessed at one month postpartum
α-tocopherol concentration in breast milk expressed in μmol/L and μg/g fat contained in the analyzed sample
Breast milk Vitamin D concentration
Time frame: Breast milk Vitamin D concentration will be assessed at one month postpartum
25-hidroxi vitamin D concentration in breast milk expressed in ng/ml
Breast milk Zinc concentration
Time frame: Breast milk Zinc concentration will be assessed at one month postpartum
Zinc concentration in breast milk expressed in mg/dl
Breast milk Calcium concentration
Time frame: Breast milk Calcium concentration will be assessed at one month postpartum
Calcium concentration in breast milk expressed in mg/dl
Breast milk Iron concentration
Time frame: Breast milk Iron concentration will be assessed at one month postpartum
Iron concentration in breast milk expressed in mg/dl
Breast milk Iodine concentration
Time frame: Breast milk Iodine concentration will be assessed at one month postpartum
Iodine concentration in breast milk expressed in mg/dl
Mother serum ferritin concentration
Time frame: Mother's serum ferritin concentration will be assessed at one month postpartum
ferritin concentration in mother serum expressed in ng/ml
mother Vit D concentration
Time frame: mother Vit D concentration will be assessed at one month postpartum
25-hidroxi vitamin D concentration in mother serum expressed in ng/ml
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 15 Sep 2025.
Related trials for Pregnancy
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fortified powder milk in people with Pregnancy, run by Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri at 2 sites in Argentina.
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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Argentina. 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?
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?
Contact Maria F Andreoli, PhD (542214177324, mfandreoli@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breast milk DHA concentration (time frame: Time Frame: breast milk DHA concentration will be assessed at one month postpartum.). The study lists 15 primary outcomes in all. 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 15 Sep 2025.