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

Bayer

Status: Completed

Conditions: Healthy Lactating Mother

Treatments: Dietary Supplement: Elevit Breastfeeding & Postnatal Care; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04462939

18737

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

68 participants in 2 patient groups, including a placebo group

Healthy lactating women - Supplement

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Elevit Breastfeeding & Postnatal Care

Healthy lactating women - Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo