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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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)] |
|
| 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)] |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elevit Pregnancy 2nd & 3rd Trimester | Dietary Supplement | Once daily micronutrient plus DHA supplementation (Multi-micronutrients and docosahexaenoic acid (MMS) soft gel capsules) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline: Blood RBC EPA/wt% TFA | Red blood cell (RBC) EPA (eicosapentaenoic acid) weight percent of total fatty acids (DHA 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 % |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal Food Frequency Questionnaire FFQ | Focus on foods providing DHA | Up to GA week 34-36 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ASST Fatebenefratelli Sacco | Milan | Lombardy | 20154 | Italy | ||
| ASST Fatebenefratelli Sacco |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41225593 | Derived | 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. |
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|
| Non-Supplement | Other | Control study group of pregnant women non-supplemented with multi-micronutrients and docosahexaenoic acid (MMS) soft gel capsules |
|
| 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 | The "omega-3 index" reflects the content of EPA plus DHA in erythrocyte membranes expressed as a percentage of total erythrocyte fatty acids. | 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 % | Glutathione exists in reduced (GSH) and oxidized (GSSG) states. Reduced glutathione is the most abundant antioxidant in aerobic cells and participates in the detoxification of lipid hydroperoxides and hydrogen peroxide exerted by glutathione peroxidases. When cells are exposes to increased oxidative stress levels, GSSG accumulates and the GSH/GSSG ratio decreases. | 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 Reactive oxygen metabolites (ROMs) concentrations % | 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 8-Isoprostane concentration % | Baseline: Screening at gestational age (GA) week 11 to 13 and at GA week 24 to 26 and week 34 to 36 |
| Infant sex | At delivery |
| Infant gestational age | At delivery |
| Infant head circumference | At delivery |
| Infant weight measurements | At delivery |
| Infant length measurements | At delivery |
| Infant ponderal index | At delivery |
| Infant skinfold thickness | Triplicate measurements: triceps, biceps, suprailiac, and subscapular on left side with standard skinfold caliper operated with constant pressure of 10 g/mm2) | At delivery |
| Infant Apgar score | At delivery |
| Infant bone density | Up to 10 days after delivery |
| Umbilical cord blood gas analysis | Cord blood sample evaluations in a subset of women undergoing Caesarean section. | At delivery |
| Umbilical cord blood pH analysis | Cord blood sample evaluations in a subset of women undergoing Caesarean section. | At delivery |
| Cord blood metabolomic analysis | Cord blood sample evaluations in a subset of women undergoing Caesarean section. | At delivery |
| Placental weight | Placenta tissue sample evaluation in a subset of women undergoing caesarean section. Placental efficiency will be estimated through the feto/placental weight (F/P) ratio, calculated as birth weight divided by the placental weight. | At delivery |
| Placental biometric parameters | Placenta tissue sample evaluation in a subset of women undergoing caesarean section. i.e. larger (D) and smaller (d) diameters of the chorionic elliptical disc, feto/placental weight (F/P ratio) | At delivery |
| Blood, cord blood and placental RBC DHA/wt% TFA | Sample evaluations in a subset of women undergoing Caesarean section. | At delivery |
| Blood, cord blood and placental RBC EPA wt% TFA | Sample evaluations in a subset of women undergoing Caesarean section. | At delivery |
| Blood, cord blood and placental DHA/TFA ratio % | Sample evaluations in a subset of women undergoing Caesarean section. | At delivery |
| Blood, cord blood and placental RBC Omega 3 index | Sample evaluations in a subset of women undergoing Caesarean section. | At delivery |
| Mitochondrial DNA content evaluation in placental tissue and isolated trophoblast cells | mtDNA is a well-accepted molecular marker to assess mitochondria content. Sample evaluations in a subset of women undergoing Caesarean section. | At delivery |
| IL-6 (Interleukin 6), IL-10 (Interleukin 10) and TNF-α (Tumor Necrosis Factor Alpha) in placental tissue and isolated trophoblast cells | These genes are constitutively expressed in human placenta and are a reliable marker of inflammation. Sample evaluations in a subset of women undergoing Caesarean section. | At delivery |
| Placental tissue metabolomic analysis | Sample evaluations in a subset of women undergoing Caesarean section. The rationale for conducting metabolomic analysis is to understand if multi-micronutrient supplement (MMS) supplementation during the second and third trimester of pregnancy influences maternal and infant gestational outcomes (e.g. oxidative stress, placental function). | At delivery |
| Blood, cord blood and placental 8-isoprostane | Sample evaluations in a subset of women undergoing Caesarean section. | At delivery |
| Blood, cord blood and placental reactive oxygen metabolites (ROMs) concentrations % | Sample evaluations in a subset of women undergoing Caesarean section. | At delivery |
| Number of Adverse Events (AEs) | Within 7 days after Delivery |
| Severity of AEs | Within 7 days after Delivery |
| AE relationship to the investigational product | Within 7 days after Delivery |
| Milan |
| Lombardy |
| 20157 |
| Italy |
| ID | Term |
|---|---|
| D011263 | Pregnancy Trimester, Third |
| ID | Term |
|---|---|
| D011264 | Pregnancy Trimesters |
| D055703 | Reproductive Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
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