Clinical Study on the Effect of Elevit Pregnancy 2nd & 3rd Trimester (Multi-micronutrients & DHA Supplement) on the Nutritional Status of Pregnant Women During Second and Third Trimester

Bayer

Status: Completed

Conditions: Healthy Pregnant Women

Treatments: Other: Non-Supplement; Dietary Supplement: Elevit Pregnancy 2nd & 3rd Trimester

Study type: Interventional

Funder types: Industry

Identifiers

NCT04438928

18366

Details and patient eligibility

About

The aim of this study is to collect information how adding a soft gel preparation of micronutrients such as vitamins, dietary minerals plus omega-3 fatty acid (docosahexaenoic acid, DHA) to the diet of pregnant women during the 2nd and 3rd trimesters of pregnancy effects the nutritional state of the mother and infants at delivery.

Enrollment: 164 patients

Sex: Female

Ages: 18 to 42 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy pregnant Caucasian women aged 18 to 42 years (inclusive) in their 1st - 2nd trimester (gestational age (GA) week 11-14 at screening);
• Hemoglobin (Hg) > 105g/L;
• Inconspicuous fetal anomaly screening;
• Normal ultrasound examination (Ultra Sonography (USG));
• Singleton pregnancy;
• Taking at least 400 mcg folate per day;
• 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 supplementation plan, to laboratory tests and to all other study related procedures according to the clinical protocol;
• Pregnant women providing a personally signed and dated given informed consent to participate in the study and to adhere to all study procedures 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.

Exclusion criteria

• Physical (including vital signs e.g. blood pressure and pulse rate), hematological and clinical-chemical parameters deviating from normal and with clinical relevance;
• Any infection (acute or chronic) at screening and baseline;
• Any current metabolic diseases (e.g. diabetes, hypothyroidism);
• Less than 12 months from previous delivery;
• Any history 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 or current neurological, cardiac, endocrine or bleeding disorders;
• Specific diets (e.g. vegan vegetarian, celiac, lactose free);
• Body mass index (BMI) < 18 or >30 kg/m2;
• Pregnant women already taking DHA/multivitamin supplements (except folate or iron);
• Diagnosed or suspected malignant or premalignant disease;
• Current clinically significant depression;
• Current intake of pharmaceuticals or dietary supplements which may interact with any of the ingredients of the trial treatment (i.e. fluoroquinolones, bisphosphonates, levodopa, levothyroxine, penicillamine, antibiotics containing tetracycline or trietine);
• History of or current diseases where vitamin, mineral, trace element 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];
• Severe Hyperemesis gravidarum;
• Previous adverse birth outcomes (e.g. small for gestational age, low birth weight, premature birth, stillbirth, more than two consecutive spontaneous abortions);
• Previous adverse pregnancy outcomes (e.g. gestational diabetes);
• Diagnosed congenital abnormalities in current or previous pregnancy;
• Known carrier or affected with a genetic disease or condition (e.g. mutation carrier for autosomal recessive diseases);
• History of or current abuse of drugs, alcohol or other substances;
• Current smokers and women who smoked during current pregnancy;
• Any history of hypersensitivity or known allergy to any of the ingredients of the study supplement.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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164 participants in 2 patient groups

Healthy pregnant women - Supplement

Experimental group

Description:

Supplementation with micronutrients plus docosahexaenoic acid (DHA) preparation (Multimicronutrients and docosahexaenoic acid (MMS) soft gel capsules) during 2nd and 3rd trimesters of pregnancy. Subgroup: Healthy pregnant women with Caesarean section \[A subset of subjects (approximately 10 subjects per study arm) undergoing elective Caesarean section (for reasons independent from the study)\]

Treatment:

Dietary Supplement: Elevit Pregnancy 2nd & 3rd Trimester

Healthy pregnant women - Non-Supplement

Other group

Description:

Control study group Subgroup: Healthy pregnant women with Caesarean section \[A subset of subjects (approximately 10 subjects per study arm) undergoing elective Caesarean section (for reasons independent from the study)\]

Treatment:

Other: Non-Supplement