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

NCT ID: NCT04438928

Last Updated: 2020-11-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 164 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-27
• Study Completion Date: 2019-12-05

Brief Summary

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.

Conditions

Healthy Pregnant Women

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Healthy pregnant women - Supplement

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)]

Group Type: EXPERIMENTAL

Elevit Pregnancy 2nd & 3rd Trimester

Intervention Type: DIETARY_SUPPLEMENT

Once daily micronutrient plus DHA supplementation (Multi-micronutrients and docosahexaenoic acid (MMS) soft gel capsules)

Healthy pregnant women - Non-Supplement

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)]

Group Type: OTHER

Non-Supplement

Intervention Type: OTHER

Control study group of pregnant women non-supplemented with multi-micronutrients and docosahexaenoic acid (MMS) soft gel capsules

Interventions

Elevit Pregnancy 2nd & 3rd Trimester

Once daily micronutrient plus DHA supplementation (Multi-micronutrients and docosahexaenoic acid (MMS) soft gel capsules)

Intervention Type: DIETARY_SUPPLEMENT

Non-Supplement

Control study group of pregnant women non-supplemented with multi-micronutrients and docosahexaenoic acid (MMS) soft gel capsules

Intervention Type: OTHER

Other Intervention Names

BAY 987765 Multi-micronutrient & DHA

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

ASST Fatebenefratelli Sacco

Milan, Lombardy, Italy

ASST Fatebenefratelli Sacco

Milan, Lombardy, Italy

Countries

Italy

Other Identifiers

18366

Identifier Type: -

Identifier Source: org_study_id