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

NCT04462939 | Completed

• 1 other identifier: 18737
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 3

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.

Conditions

Healthy Lactating Mother

Outcome Measures

Primary Outcomes (1)

• 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.

  At Baseline and 6 weeks and 12 weeks

Secondary Outcomes (14)

• Change from baseline in blood parameters: % concentration relative to total milk

  At Baseline and 6 weeks and 12 weeks

• Change from baseline in milk parameters: % concentration relative to total milk

  At Baseline and 6 weeks and 12 weeks

• Change from baseline: maternal height

  At Baseline and 12 weeks

• Change from baseline: maternal weight

  At Baseline and 12 weeks

• Change from baseline: Maternal BMI kg/m2

  At Baseline and 12 weeks

Study Arms (2)

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.

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.

Drug: Placebo

Interventions

Elevit Breastfeeding & Postnatal Care DIETARY_SUPPLEMENT

Multi-micronutrients, lutein and DHA soft gel capsules; one capsule daily, oral

Also known as: BAY987816 - Multi-micronutrients, lutein & DHA

Healthy lactating women - Supplement

Placebo DRUG

No active ingredients except of 225 μg iodine; One capsule daily, oral

Healthy lactating women - Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (3)

Gynäkologische Gemeinschaftspraxis Freising

Freising, Bavaria, 85354, Germany

Location

Praxis Hr. E. Goeckeler-Leopold

Geseke, North Rhine-Westphalia, 59590, Germany

Location

Praxis Fr. Dr. K. Maar

Berlin, 13507, Germany

Location

MeSH Terms

Interventions

Postnatal Care; Lutein

Intervention Hierarchy (Ancestors)

Perinatal Care; Patient Care; Therapeutics; Maternal Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Xanthophylls; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: July 8, 2020
• Study Start: April 26, 2017
• Primary Completion: November 12, 2019
• Study Completion: November 12, 2019
• Last Updated: July 8, 2020

Record last verified: 2020-07

Locations

DE (3)