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

NCT04438928 | Completed

• 1 other identifier: 18366
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Change from baseline: Blood RBC DHA/wt% TFA

  In order to assess the beneficial effects of supplementation with micronutrients and DHA (docosahexaenoic acid) during 2nd and 3rd trimesters of pregnancy, the red blood cell (RBC) DHA weight percent of total fatty acids (DHA wt% TFA) will be measured compared to baseline as primary maternal variable. Gestational age is a measure of the age of a pregnancy which is taken from the beginning of the woman's last menstrual period (LMP), or the corresponding age of the gestation as estimated by a more accurate method if available. Such methods include adding 14 days to a known duration since fertilization (as is possible in in vitro fertilization), or by obstetric ultrasonography. The popularity of using such a definition of gestational age is that menstrual periods are essentially always noticed, while there is usually a lack of a convenient way to discern when fertilization occurred.

  Baseline: Screening at gestational age (GA) week 11 to 13 and at GA week 24 to 26 and week 34 to 36

Secondary Outcomes (33)

• Change from baseline: Blood RBC EPA/wt% TFA

  Baseline: Screening at gestational age (GA) week 11 to 13 and at GA week 24 to 26 and week 34 to 36

• Change from baseline: Blood RBC DHA/TFA ratio %

  Baseline: Screening at gestational age (GA) week 11 to 13 and at GA week 24 to 26 and week 34 to 36

• Change from baseline: Blood RBC Omega 3 index in RBC

  Baseline: Screening at gestational age (GA) week 11 to 13 and at GA week 24 to 26 and week 34 to 36

• Change from baseline: Blood 25-hydroxyvitamin D concentration %

  Baseline: Screening at gestational age (GA) week 11 to 13 and at GA week 24 to 26 and week 34 to 36

• Change from baseline: Blood Glutathione (GSH)/oxidized Glutathione (GSSG) ratio %

  Baseline: Screening at gestational age (GA) week 11 to 13 and at GA week 24 to 26 and week 34 to 36

Other Outcomes (1)

• Maternal Food Frequency Questionnaire FFQ

  Up to GA week 34-36

Study Arms (2)

Healthy pregnant women - Supplement

EXPERIMENTAL

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 \[A subset of subjects (approximately 10 subjects per study arm) undergoing elective Caesarean section (for reasons independent from the study)\]

Dietary Supplement: Elevit Pregnancy 2nd & 3rd Trimester

Healthy pregnant women - Non-Supplement

OTHER

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

Other: Non-Supplement

Interventions

Elevit Pregnancy 2nd & 3rd Trimester DIETARY_SUPPLEMENT

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

Also known as: BAY 987765 Multi-micronutrient & DHA

Healthy pregnant women - Supplement

Non-Supplement OTHER

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

Healthy pregnant women - Non-Supplement

Eligibility Criteria

• Age: 18 Years - 42 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Bayer: lead

Study Sites (2)

ASST Fatebenefratelli Sacco

Milan, Lombardy, 20154, Italy

Location

ASST Fatebenefratelli Sacco

Milan, Lombardy, 20157, Italy

Location

Related Publications (1)

• Parisi F, Mando C, Novielli C, Anelli GM, Cazzola R, Lisso F, Sarno L, Marelli E, Lubrano C, Maria Antonazzo PG, Cetin I. Maternal mid-pregnancy long-chain polyunsaturated fatty acid profile is associated with pregestational body mass index and neonatal anthropometric measures at birth among non-obese pregnancies: results from two Italian multicenter cohorts. Nutr Metab (Lond). 2025 Nov 12;22(1):137. doi: 10.1186/s12986-025-01034-8.

  PMID: 41225593 DERIVED

MeSH Terms

Interventions

Pregnancy Trimester, Third

Intervention Hierarchy (Ancestors)

Pregnancy Trimesters; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

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: June 19, 2020
• Study Start: September 27, 2016
• Primary Completion: December 5, 2019
• Study Completion: December 5, 2019
• Last Updated: November 16, 2020

Record last verified: 2020-11

Locations

IT (2)