- ICH GCP
- US Clinical Trials Registry
- 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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Berlin, Germany, 13507
- Praxis Fr. Dr. K. Maar
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Bayern
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Freising, Bayern, Germany, 85354
- Gynäkologische Gemeinschaftspraxis Freising
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Nordrhein-Westfalen
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Geseke, Nordrhein-Westfalen, Germany, 59590
- Praxis Hr. E. Goeckeler-Leopold
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Healthy lactating women - Supplement
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.
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Multi-micronutrients, lutein and DHA soft gel capsules; one capsule daily, oral
Other Names:
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Placebo Comparator: Healthy lactating women - Placebo
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.
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No active ingredients except of 225 μg iodine; One capsule daily, oral
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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The primary endpoint will be analyzed using the analysis of covariance (ANCOVA) with supplementation as fixed effect and baseline value as covariate.
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At Baseline and 6 weeks and 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change from baseline in blood parameters: % concentration relative to total milk
Time Frame: At Baseline and 6 weeks and 12 weeks
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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)
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At Baseline and 6 weeks and 12 weeks
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Change from baseline in milk parameters: % concentration relative to total milk
Time Frame: At Baseline and 6 weeks and 12 weeks
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Total lipids; DHA/total FA ratio; Milk macronutrient content; IFN-gamma; TGF-beta; Alpha-tocopherol and retinol; Carotenoids (lutein, zeaxanthin, beta-cryptoxanthin, lycopene, carotene)
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At Baseline and 6 weeks and 12 weeks
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Change from baseline: maternal height
Time Frame: At Baseline and 12 weeks
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At Baseline and 12 weeks
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Change from baseline: maternal weight
Time Frame: At Baseline and 12 weeks
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At Baseline and 12 weeks
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Change from baseline: Maternal BMI kg/m2
Time Frame: At Baseline and 12 weeks
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At Baseline and 12 weeks
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Change from baseline: Maternal fatigue questionnaire
Time Frame: At Baseline and 6 weeks and 12 weeks
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At Baseline and 6 weeks and 12 weeks
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Change from baseline: Maternal food frequancy questionnaire
Time Frame: At Baseline and 6 weeks and 12 weeks
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At Baseline and 6 weeks and 12 weeks
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Change from baseline: Infant weight
Time Frame: At Baseline and 6 weeks and 12 weeks
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At Baseline and 6 weeks and 12 weeks
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Change from baseline: Infant length
Time Frame: At Baseline and 6 weeks and 12 weeks
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At Baseline and 6 weeks and 12 weeks
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Change from baseline: Infant Calculation of Weight Standard Deviation Scores (SDS)
Time Frame: At Baseline and 6 weeks and 12 weeks
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At Baseline and 6 weeks and 12 weeks
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Change from baseline: Infant Calculation of Length Standard Deviation Scores (SDS)
Time Frame: At Baseline and 6 weeks and 12 weeks
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At Baseline and 6 weeks and 12 weeks
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Number of Adverse Events (AEs)
Time Frame: Up to 13 weeks
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Up to 13 weeks
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Severity of AEs
Time Frame: Up to 13 weeks
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Up to 13 weeks
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AE relationship to the investigational product
Time Frame: Up to 13 weeks
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Up to 13 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18737
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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