Lactating MothersNCT06319079
Effect of Consumption of a Milk Product Designed for Lactating Women on Human Milk Composition
A study testing Fortified powder milk and Powder milk in people with Lactating Mothers and Infants, run by Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri at 1 site 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
- Lactating Mothers, Infants
- What is being tested?
- Fortified powder milk and Powder milk
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Jun 2024to 1 Jul 2027
- 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
- Women who attend their child's first check-up within the first month of life, who breastfeed their children, and who consume milk regularly.
Who cannot join
- Women who have had multiple pregnancies, who receive vitamin or mineral supplements that interfere with the results of the study, and/or women with malabsorption diseases.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Argentina1 site, 1 recruiting
- Recruiting
Instituto de Desarrollo e Investigaciones Pediátricas (IDIP) - HIAEP Sor María Ludovica
La Plata, Buenos Aires, 1900
Ignacio Agustin I Mendez, MS Nutrition, 541158671615 ext. 54221 417-7324, ignacioagustinmg@gmail.com
About this study
Official title: Effect of Consumption of a Milk Product Designed for Lactating Women on Human Milk Composition and Nutritional Status of Iron and DHA in Infant Red Blood Cells.. 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 ) has been designed and developed as part of a key strategy to incorporate in 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 lactating women on the composition of human milk and the nutritional status of iron and DHA in infant red blood cells in a vulnerable population through a randomized, triple-blind, controlled clinical trial.
Read more
Specific objectives To compare the concentrations of DHA, Vitamins A, E, and D, Iron, Iodine, Zinc and Calcium in human milk before and after dietary supplementation with SMM.
To compare the concentrations of DHA, Vitamins A, E, D and Zinc in blood and the nutritional status of maternal iron before and after dietary supplementation with SMM.
To analyze the relationship between micronutrients measured in maternal blood and human milk after dietary supplementation with SMM.
To compare the concentrations of micronutrients measured in blood and human milk in women who received SMM and those who received commercial milk (CM) at the end of supplementation.
To compare the iron nutritional status and DHA content in red blood cells of infants of mothers who consumed SMM or LC.
To evaluate the relationship between the concentration of micronutrients in human milk and infant growth during the first six months of life.
- Conditions
- Lactating Mothers, Infants
- Being tested
- Fortified powder milk, Powder milk
- Keywords
- human milk, vulnerable population, micronutrients, esencial fatty acids, nutritional supplements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fortified powder milkDietary supplement
Also called Super 1.000 Mamá
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.
Powder milkOther
Also called Commercial powder milk
Commercial powder milk constitutes dehydrated commercially available cow's milk, which is fortified with Vitamins A and D by law.
| Study group | Role | What they receive |
|---|---|---|
| Super 1.000 Mamá | Experimental | Breastfeeding mothers who breastfeed their children during the first four months postpartum will receive a fortified powder milk product formulated and designed specifically for this population. Receives: Dietary Supplement: Fortified powder milk |
| Leche comercial | Sham comparator | Breastfeeding mothers who breastfeed their children during the first four months postpartum will receive commercial powder milk. Receives: Other: Powder milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
breast milk DHA concentration
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: breast milk DHA concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth 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 assessed before starting the intervention (one month postpartum) and at the end of it (fourth 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 assessed before starting the intervention (one month postpartum) and at the end of it (fourth 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 assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
breast milk Zinc concentration
Zinc concentration in breast milk expressed in mg/dl
Measured: breast milk Zinc concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
breast milk Calcium concentration
Calcium concentration in breast milk expressed in mg/dl
Measured: breast milk Calcium concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
breast milk Iron concentration
Calcium concentration in breast milk expressed in mg/dl
Measured: breast milk Iron concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
breast milk Iodine concentration
Iodine concentration in breast milk expressed in mg/dl
Measured: breast milk Iodine concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
Secondary outcomes (10)
mother red blood cell DHA concentration
concentration of DHA in mother red blood cell expressed as a percentage of DHA with respect to the total fatty acids contained in the analyzed sample
Measured: mother serum DHA concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
mother Vit A concentration
Retinol concentration in mother serum expressed in μmol/L
Measured: mother Vit A concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
mother Vit E concentration
α-tocopherol concentration in mother serum expressed in μmol/L
Measured: mother Vit E concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
mother Vit D concentration
25-hidroxi vitamin D concentration in mother serum expressed in ng/ml
Measured: mother Vit D concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
mother Zinc concentration
Zinc concentration in mother serum expressed in mg/dl
Measured: mother Zinc concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
mother hemoglobin concentration
hemoglobin concentration in mother serum expressed in g/dL
Measured: mother hemoglobin concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
mother serum ferritin concentration
ferritin concentration in mother serum expressed in ng/ml
Measured: mother serum ferritin concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
child hemoglobin concentration
hemoglobin concentration in child serum expressed in g/dL
Measured: child hemoglobin concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
child serum ferritin concentration
ferritin concentration in child serum expressed in ng/ml
Measured: child serum ferritin concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
child red blood cell DHA concentration
concentration of DHA in child red blood cell expressed as a percentage of DHA with respect to the total fatty acids contained in the analyzed sample
Measured: child red blood cell DHA concentration concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start1 Jun 2024
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lactating MothersStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06319079
- Sponsor's protocol ID
- UCTH 2024
- Status last verified
- Sep 2024
- First submitted
- 12 Mar 2024
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Consumption of a Milk Product Designed for Lactating Women on Human Milk Composition and Nutritional Status of Iron and DHA in Infant Red Blood Cells.. Study in a Vulnerable Population.
- ClinicalTrials.gov ID
- NCT06319079
- Acronym / sponsor ID
- UCTH 2024
- Conditions
- Lactating Mothers, Infants
- Keywords
- human milk, vulnerable population, micronutrients, esencial fatty acids, nutritional supplements
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. ViteriUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 19 Mar 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.
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 ) has been designed and developed as part of a key strategy to incorporate in 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 lactating women on the composition of human milk and the nutritional status of iron and DHA in infant red blood cells in a vulnerable population through a randomized, triple-blind, controlled clinical trial.
Specific objectives To compare the concentrations of DHA, Vitamins A, E, and D, Iron, Iodine, Zinc and Calcium in human milk before and after dietary supplementation with SMM.
To compare the concentrations of DHA, Vitamins A, E, D and Zinc in blood and the nutritional status of maternal iron before and after dietary supplementation with SMM.
To analyze the relationship between micronutrients measured in maternal blood and human milk after dietary supplementation with SMM.
To compare the concentrations of micronutrients measured in blood and human milk in women who received SMM and those who received commercial milk (CM) at the end of supplementation.
To compare the iron nutritional status and DHA content in red blood cells of infants of mothers who consumed SMM or LC.
To evaluate the relationship between the concentration of micronutrients in human milk and infant growth during the first six months of life.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Super 1.000 Mamá | Experimental | Dietary Supplement: Fortified powder milkBreastfeeding mothers who breastfeed their children during the first four months postpartum will receive a fortified powder milk product formulated and designed specifically for this population. |
| Leche comercial | Sham comparator | Other: Powder milkBreastfeeding mothers who breastfeed their children during the first four months postpartum will receive commercial powder milk. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women who attend their child's first check-up within the first month of life, who breastfeed their children, and who consume milk regularly.
Key exclusion criteria (1 listed)
- Women who have had multiple pregnancies, who receive vitamin or mineral supplements that interfere with the results of the study, 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 milkAlso: Super 1.000 MamáSuper 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 | Super 1.000 Mamá |
| Powder milkAlso: Commercial powder milkCommercial powder milk constitutes dehydrated commercially available cow's milk, which is fortified with Vitamins A and D by law. | Other | Leche comercial |
Primary outcome
breast milk DHA concentration
Time frame: breast milk DHA concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
concentration of DHA in breast milk expressed as a percentage of DHA with respect to the total fatty acids contained in the analyzed sample
breast milk Vitamin A concentration
Time frame: breast milk Vitamin A concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth 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 assessed before starting the intervention (one month postpartum) and at the end of it (fourth 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 assessed before starting the intervention (one month postpartum) and at the end of it (fourth 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 assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
Zinc concentration in breast milk expressed in mg/dl
breast milk Calcium concentration
Time frame: breast milk Calcium concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
Calcium concentration in breast milk expressed in mg/dl
breast milk Iron concentration
Time frame: breast milk Iron concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
Calcium concentration in breast milk expressed in mg/dl
breast milk Iodine concentration
Time frame: breast milk Iodine concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
Iodine concentration in breast milk expressed in mg/dl
10 secondary outcomes
mother red blood cell DHA concentration
Time frame: mother serum DHA concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
mother Vit A concentration
Time frame: mother Vit A concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
mother Vit E concentration
Time frame: mother Vit E concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
mother Vit D concentration
Time frame: mother Vit D concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
mother Zinc concentration
Time frame: mother Zinc concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
mother hemoglobin concentration
Time frame: mother hemoglobin concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
mother serum ferritin concentration
Time frame: mother serum ferritin concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
child hemoglobin concentration
Time frame: child hemoglobin concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
child serum ferritin concentration
Time frame: child serum ferritin concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
child red blood cell DHA concentration
Time frame: child red blood cell DHA concentration concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
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 27 Sep 2024.
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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.
1 site 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 and Powder milk in people with Lactating Mothers and Infants, run by Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri at 1 site 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 1 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 27 Sep 2024. 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 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. Some participants in this study may receive a placebo. 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 Florencia 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: breast milk DHA concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)). The study lists 8 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 27 Sep 2024.