Clinical trial NCT04462939: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Lactating Mother
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2020-07-08
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.


Eligibility criteria: Inclusion Criteria for women:

* 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;
* 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.

Inclusion Criteria for infants:

* 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.

Exclusion Criteria for women:

* 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;
* 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).

Primary outcomes:
measure: Change from baseline in human milk total lipid docosahexaenoic acid (DHA) content: % DHA concentration relative to total milk
timeFrame: At Baseline and 6 weeks and 12 weeks
Secondary outcomes:
measure: Change from baseline in blood parameters: % concentration relative to total milk
timeFrame: At Baseline and 6 weeks and 12 weeks
measure: Change from baseline in milk parameters: % concentration relative to total milk
timeFrame: At Baseline and 6 weeks and 12 weeks
measure: Change from baseline: maternal height
timeFrame: At Baseline and 12 weeks
measure: Change from baseline: maternal weight
timeFrame: At Baseline and 12 weeks
measure: Change from baseline: Maternal BMI kg/m2
timeFrame: At Baseline and 12 weeks
measure: Change from baseline: Maternal fatigue questionnaire
timeFrame: At Baseline and 6 weeks and 12 weeks
measure: Change from baseline: Maternal food frequancy questionnaire
timeFrame: At Baseline and 6 weeks and 12 weeks
measure: Change from baseline: Infant weight
timeFrame: At Baseline and 6 weeks and 12 weeks
measure: Change from baseline: Infant length
timeFrame: At Baseline and 6 weeks and 12 weeks
measure: Change from baseline: Infant Calculation of Weight Standard Deviation Scores (SDS)
timeFrame: At Baseline and 6 weeks and 12 weeks
measure: Change from baseline: Infant Calculation of Length Standard Deviation Scores (SDS)
timeFrame: At Baseline and 6 weeks and 12 weeks
measure: Number of Adverse Events (AEs)
timeFrame: Up to 13 weeks
measure: Severity of AEs
timeFrame: Up to 13 weeks
measure: AE relationship to the investigational product
timeFrame: Up to 13 weeks
Other outcomes:
Locations:
city: Freising
country: Germany
facility: Gynäkologische Gemeinschaftspraxis Freising
state: Bayern
city: Geseke
country: Germany
facility: Praxis Hr. E. Goeckeler-Leopold
state: Nordrhein-Westfalen
city: Berlin
country: Germany
facility: Praxis Fr. Dr. K. Maar
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: