Healthy Lactating MotherNCT04462939
Study to Learn About the Effect of Elevit (a Food Supplement Containing Several Vitamins, Minerals, Lutein and DHA) on the Nutrient Content in the Breast Milk and Blood of Women During Breastfeeding Period and on Babies' Physical Growth Parameters
A study testing Elevit Breastfeeding & Postnatal Care in people with Healthy Lactating Mother, run by Bayer at 3 sites in Germany.
Trial summary
The aim of the study is to learn about the effect of multi-micronutrient, lutein and DHA supplementation (Elevit Breastfeeding \& Postnatal Care) on the breast milk nutrient composition and babies physical growth parameters. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Lactating Mother
- What is being tested?
- Elevit Breastfeeding & Postnatal Care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 3 sitesGermany
- Study dates
- 26 Apr 2017to 12 Nov 2019
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy pregnant women aged 18 to 45 years (inclusive) in their third trimester of pregnancy who are expected to give birth to a healthy single full-term infant;
- Hb > 105 g/L;
- Intention to breastfeed for at least four months (no more than one bottle or 10% of total milk intake daily as formula);
- Omnivorous diet;
- Not intent to take multivitamin supplements, DHA supplements, lutein supplements or any combination of the aforementioned after giving birth except for iodine and iron;
- Seronegative for Human Immunodeficiency Virus (HIV), Hepatitis B, and Hepatitis C at screening;
Show all 11Show fewer
- Pregnant women who, in the opinion of the Investigator, are willing and able to participate in all scheduled visits, to adhere to the study plan, to laboratory tests and to all other study related procedures according to the clinical protocol;
- Pregnant women providing a personally signed and dated informed consent willing to participate in the study and to adhere to all study procedures including the assessments done to the infant, indicating that they have been informed of all pertinent aspects of the trial and that they understood and accepted these, prior to admission to the study.
- Full term/gestational age > 37 weeks < 43 weeks and birth weight adequate for gestational age;
- Apgar score at 5 minutes after birth > 7;
- No indication of abnormal neurodevelopment.
Who cannot join
- Physical (including vital signs e.g. blood pressure, pulse rate), hematological and clinical-chemical parameters deviating from normal and with clinical relevance in the opinion of the investigator;
- Any serious infection (acute or chronic) at screening and randomization;
- Any history of or current metabolic diseases (e.g. diabetes, hypothyroidism, and other metabolic diseases);
- Less than 12 months from previous delivery;
- Any history of or current diseases, which are associated with malabsorption, or other severe diseases of the gastrointestinal tract (e.g. chronic inflammatory bowel disease, iron accumulation, iron utilization disorders);
- Any history of or current neurological, cardiac, endocrine or bleeding disorders;
Show all 21Show fewer
- Specific diets (e.g. vegan, vegetarian, celiac);
- Pre-pregnancy body mass index (BMI) < 18.5 or > 30 kg/m2;
- Diagnosed or suspected malignant or premalignant disease;
- Current clinically significant depression;
- Not willing, or unable for medical reasons to interrupt any intake of pharmaceuticals or dietary supplements which may interact with any of the ingredients of the trial product (i.e. fluoroquinolones, bisphosphonates, levodopa, levothyroxine, penicillamine, antibiotics containing tetracycline or trietine) during the study supplementation period (From Visit 2 (Randomization) until Visit 4 (EoS));
- History of or current diseases where vitamin, mineral, trace element, lutein or DHA supplementation might be not recommended / contraindicated (such as sickle cell anemia, copper metabolism disorders (Wilson's disease), renal disease, nephrolithiasis, urolithiasis, hypercalcemia, hypercalciuria, hepatobiliary diseases, existing hypervitaminosis, iron metabolism disorders, hypermagnesemia);
- Any pregnancy complications or adverse pregnancy outcomes in current pregnancy that may affect micronutrient metabolism or status (e.g. preeclampsia, eclampsia, polyhydramniosis, placental insufficiency);
- Diagnosed congenital abnormalities in current pregnancy;
- Current smoker or smoker during current pregnancy.
- Main exclusion criteria for infants:
- Congenital anomalies;
- Obvious gastrointestinal or metabolic disorders;
- Perinatal hypoxia;
- Preterm birth;
- Very low birth weight (VLBW).
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Praxis Fr. Dr. K. Maar
Berlin, 13507
Gynäkologische Gemeinschaftspraxis Freising
Freising, Bavaria, 85354
Praxis Hr. E. Goeckeler-Leopold
Geseke, North Rhine-Westphalia, 59590
About this study
Official title: Effects of Multiple Micronutrients, Lutein and Docosahexaenoic Acid (DHA) Supplementation During Lactation on Human Milk Nutrient Content, Maternal Blood Biomarkers and Infant Anthropometric Parameters
The aim of the study is to learn about the effect of multi-micronutrient, lutein and DHA supplementation (Elevit Breastfeeding \& Postnatal Care) on the breast milk nutrient composition and babies physical growth parameters.
Mothers participating in this study received either Elevit or placebo orally once a day for 12 weeks starting from 4 to 6 weeks after delivery. Blood, urine and milk samples were collected from the mothers and physical parameters like size and weight were collected from the babies to assess the effect of the supplementation.
- Conditions
- Healthy Lactating Mother
- Being tested
- Elevit Breastfeeding & Postnatal Care, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elevit Breastfeeding & Postnatal CareDietary supplement
Also called BAY987816 - Multi-micronutrients, lutein & DHA
Multi-micronutrients, lutein and DHA soft gel capsules; one capsule daily, oral
PlaceboDrug
No active ingredients except of 225 μg iodine; One capsule daily, oral
| Study group | Role | What they receive |
|---|---|---|
| Healthy lactating women - Supplement | Experimental | At randomization (Visit 2), from four to six weeks after delivery, eligible actating women will be equally randomized to one of the study arms (supplementation arm or placebo arm) and will assume the supplement or placebo once daily for a duration of 12 weeks. Receives: Dietary Supplement: Elevit Breastfeeding & Postnatal Care |
| Healthy lactating women - Placebo | Placebo comparator | At randomization (Visit 2), from four to six weeks after delivery, eligible actating women will be equally randomized to one of the study arms (supplementation arm or placebo arm) and will assume the supplement or placebo once daily for a duration of 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in human milk total lipid docosahexaenoic acid (DHA) content: % DHA concentration relative to total milk
The primary endpoint will be analyzed using the analysis of covariance (ANCOVA) with supplementation as fixed effect and baseline value as covariate.
Measured: At Baseline and 6 weeks and 12 weeks
Secondary outcomes (14)
Change from baseline in blood parameters: % concentration relative to total milk
Fatty acids (FA) in plasma and glycerophospholipids (GPL); DHA/total fatty acid (TFA) ratio; IFN-gamma; TGF-beta; Folic acid, Vitamin B12 and homocystein; 25-Hydroxivitamin D; Alpha-tocopherol and retinol; Carotenoids (lutein, zeaxanthin, beta-cryptoxanthin, lycopene, carotene)
Measured: At Baseline and 6 weeks and 12 weeks
Change from baseline in milk parameters: % concentration relative to total milk
Total lipids; DHA/total FA ratio; Milk macronutrient content; IFN-gamma; TGF-beta; Alpha-tocopherol and retinol; Carotenoids (lutein, zeaxanthin, beta-cryptoxanthin, lycopene, carotene)
Measured: At Baseline and 6 weeks and 12 weeks
Change from baseline: maternal height
Measured: At Baseline and 12 weeks
Change from baseline: maternal weight
Measured: At Baseline and 12 weeks
Change from baseline: Maternal BMI kg/m2
Measured: At Baseline and 12 weeks
Change from baseline: Maternal fatigue questionnaire
Measured: At Baseline and 6 weeks and 12 weeks
Change from baseline: Maternal food frequancy questionnaire
Measured: At Baseline and 6 weeks and 12 weeks
Change from baseline: Infant weight
Measured: At Baseline and 6 weeks and 12 weeks
Change from baseline: Infant length
Measured: At Baseline and 6 weeks and 12 weeks
Change from baseline: Infant Calculation of Weight Standard Deviation Scores (SDS)
Measured: At Baseline and 6 weeks and 12 weeks
Change from baseline: Infant Calculation of Length Standard Deviation Scores (SDS)
Measured: At Baseline and 6 weeks and 12 weeks
Number of Adverse Events (AEs)
Measured: Up to 13 weeks
Severity of AEs
Measured: Up to 13 weeks
AE relationship to the investigational product
Measured: Up to 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start26 Apr 2017
- Primary completion12 Nov 2019
- Study completion12 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Lactating MotherStudies of the same condition, open and under way.
- More trials run by BayerThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04462939
- Sponsor's protocol ID
- 18737
- Status last verified
- Jul 2020
- First submitted
- 29 May 2020
- Last updated
- 8 Jul 2020
- 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 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Multiple Micronutrients, Lutein and Docosahexaenoic Acid (DHA) Supplementation During Lactation on Human Milk Nutrient Content, Maternal Blood Biomarkers and Infant Anthropometric Parameters
- ClinicalTrials.gov ID
- NCT04462939
- Acronym / sponsor ID
- 18737
- Conditions
- Healthy Lactating Mother
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 26 Apr 2017 (actual)
- Primary completion
- 12 Nov 2019 (actual)
- Study completion
- 12 Nov 2019 (actual)
- First posted
- 8 Jul 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.
The aim of the study is to learn about the effect of multi-micronutrient, lutein and DHA supplementation (Elevit Breastfeeding \& Postnatal Care) on the breast milk nutrient composition and babies physical growth parameters.
Mothers participating in this study received either Elevit or placebo orally once a day for 12 weeks starting from 4 to 6 weeks after delivery. Blood, urine and milk samples were collected from the mothers and physical parameters like size and weight were collected from the babies to assess the effect of the supplementation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy lactating women - Supplement | Experimental | Dietary Supplement: Elevit Breastfeeding & Postnatal CareAt randomization (Visit 2), from four to six weeks after delivery, eligible actating women will be equally randomized to one of the study arms (supplementation arm or placebo arm) and will assume the supplement or placebo once daily for a duration of 12 weeks. |
| Healthy lactating women - Placebo | Placebo comparator | Drug: PlaceboAt randomization (Visit 2), from four to six weeks after delivery, eligible actating women will be equally randomized to one of the study arms (supplementation arm or placebo arm) and will assume the supplement or placebo once daily for a duration of 12 weeks. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Healthy pregnant women aged 18 to 45 years (inclusive) in their third trimester of pregnancy who are expected to give birth to a healthy single full-term infant;
- Hb > 105 g/L;
- Intention to breastfeed for at least four months (no more than one bottle or 10% of total milk intake daily as formula);
- Omnivorous diet;
- Not intent to take multivitamin supplements, DHA supplements, lutein supplements or any combination of the aforementioned after giving birth except for iodine and iron;
Key exclusion criteria (21 listed)
- Physical (including vital signs e.g. blood pressure, pulse rate), hematological and clinical-chemical parameters deviating from normal and with clinical relevance in the opinion of the investigator;
- Any serious infection (acute or chronic) at screening and randomization;
- Any history of or current metabolic diseases (e.g. diabetes, hypothyroidism, and other metabolic diseases);
- Less than 12 months from previous delivery;
- Any history of or current diseases, which are associated with malabsorption, or other severe diseases of the gastrointestinal tract (e.g. chronic inflammatory bowel disease, iron accumulation, iron utilization disorders);
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 |
|---|---|---|
| Elevit Breastfeeding & Postnatal CareAlso: BAY987816 - Multi-micronutrients, lutein & DHAMulti-micronutrients, lutein and DHA soft gel capsules; one capsule daily, oral | Dietary supplement | Healthy lactating women - Supplement |
| PlaceboNo active ingredients except of 225 μg iodine; One capsule daily, oral | Drug | Healthy lactating women - Placebo |
Primary outcome
Change from baseline in human milk total lipid docosahexaenoic acid (DHA) content: % DHA concentration relative to total milk
Time frame: At Baseline and 6 weeks and 12 weeks
The primary endpoint will be analyzed using the analysis of covariance (ANCOVA) with supplementation as fixed effect and baseline value as covariate.
14 secondary outcomes
Change from baseline in blood parameters: % concentration relative to total milk
Time frame: At Baseline and 6 weeks and 12 weeks
Change from baseline in milk parameters: % concentration relative to total milk
Time frame: At Baseline and 6 weeks and 12 weeks
Change from baseline: maternal height
Time frame: At Baseline and 12 weeks
Change from baseline: maternal weight
Time frame: At Baseline and 12 weeks
Change from baseline: Maternal BMI kg/m2
Time frame: At Baseline and 12 weeks
Change from baseline: Maternal fatigue questionnaire
Time frame: At Baseline and 6 weeks and 12 weeks
Change from baseline: Maternal food frequancy questionnaire
Time frame: At Baseline and 6 weeks and 12 weeks
Change from baseline: Infant weight
Time frame: At Baseline and 6 weeks and 12 weeks
Change from baseline: Infant length
Time frame: At Baseline and 6 weeks and 12 weeks
Change from baseline: Infant Calculation of Weight Standard Deviation Scores (SDS)
Time frame: At Baseline and 6 weeks and 12 weeks
Change from baseline: Infant Calculation of Length Standard Deviation Scores (SDS)
Time frame: At Baseline and 6 weeks and 12 weeks
Number of Adverse Events (AEs)
Time frame: Up to 13 weeks
Severity of AEs
Time frame: Up to 13 weeks
AE relationship to the investigational product
Time frame: Up to 13 weeks
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 8 Jul 2020.
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.
Bayer Study Director study director
Bayer
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elevit Breastfeeding & Postnatal Care in people with Healthy Lactating Mother, run by Bayer at 3 sites in Germany.
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 11 inclusion and 21 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 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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?
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?
Change from baseline in human milk total lipid docosahexaenoic acid (DHA) content: % DHA concentration relative to total milk (time frame: At Baseline and 6 weeks and 12 weeks). 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 8 Jul 2020.