check_circleStudy Completed
Healthy pregnant women
Bayer Identifier:
18366
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial purpose
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.
Key Participants Requirements
Sex
FemaleAge
18 - 42 YearsTrial summary
Enrollment Goal
164Trial Dates
September 2016 - December 2019Phase
N/ACould I Receive a placebo
NoProducts
BAY987765Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | ASST Fatebenefratelli Sacco | Milano, 20157, Italy |
Completed | ASST Fatebenefratelli Sacco | Milano, 20154, Italy |
Primary Outcome
- Change from baseline: Blood RBC DHA/wt% TFAIn 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.date_rangeTime Frame:Baseline: Screening at gestational age (GA) week 11 to 13 and at GA week 24 to 26 and week 34 to 36
Secondary Outcome
- Change from baseline: Blood RBC EPA/wt% TFARed blood cell (RBC) EPA (eicosapentaenoic acid) weight percent of total fatty acids (DHA wt% TFA).date_rangeTime Frame: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 %date_rangeTime Frame: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 RBCThe “omega-3 index” reflects the content of EPA plus DHA in erythrocyte membranes expressed as a percentage of total erythrocyte fatty acids.date_rangeTime Frame: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 %date_rangeTime Frame: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.date_rangeTime Frame: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 %date_rangeTime Frame: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 %date_rangeTime Frame:Baseline: Screening at gestational age (GA) week 11 to 13 and at GA week 24 to 26 and week 34 to 36
- Infant sexdate_rangeTime Frame:At delivery
- Infant gestational agedate_rangeTime Frame:At delivery
- Infant head circumferencedate_rangeTime Frame:At delivery
- Infant weight measurementsdate_rangeTime Frame:At delivery
- Infant length measurementsdate_rangeTime Frame:At delivery
- Infant ponderal indexdate_rangeTime Frame:At delivery
- Infant skinfold thicknessTriplicate measurements: triceps, biceps, suprailiac, and subscapular on left side with standard skinfold caliper operated with constant pressure of 10 g/mm2)date_rangeTime Frame:At delivery
- Infant Apgar scoredate_rangeTime Frame:At delivery
- Infant bone densitydate_rangeTime Frame:Up to 10 days after delivery
- Umbilical cord blood gas analysisCord blood sample evaluations in a subset of women undergoing Caesarean section.date_rangeTime Frame:At delivery
- Umbilical cord blood pH analysisCord blood sample evaluations in a subset of women undergoing Caesarean section.date_rangeTime Frame:At delivery
- Cord blood metabolomic analysisCord blood sample evaluations in a subset of women undergoing Caesarean section.date_rangeTime Frame:At delivery
- Placental weightPlacenta 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.date_rangeTime Frame:At delivery
- Placental biometric parametersPlacenta 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)date_rangeTime Frame:At delivery
- Blood, cord blood and placental RBC DHA/wt% TFASample evaluations in a subset of women undergoing Caesarean section.date_rangeTime Frame:At delivery
- Blood, cord blood and placental RBC EPA wt% TFASample evaluations in a subset of women undergoing Caesarean section.date_rangeTime Frame:At delivery
- Blood, cord blood and placental DHA/TFA ratio %Sample evaluations in a subset of women undergoing Caesarean section.date_rangeTime Frame:At delivery
- Blood, cord blood and placental RBC Omega 3 indexSample evaluations in a subset of women undergoing Caesarean section.date_rangeTime Frame:At delivery
- Mitochondrial DNA content evaluation in placental tissue and isolated trophoblast cellsmtDNA is a well-accepted molecular marker to assess mitochondria content. Sample evaluations in a subset of women undergoing Caesarean section.date_rangeTime Frame:At delivery
- IL-6 (Interleukin 6), IL-10 (Interleukin 10) and TNF-α (Tumor Necrosis Factor Alpha) in placental tissue and isolated trophoblast cellsThese genes are constitutively expressed in human placenta and are a reliable marker of inflammation. Sample evaluations in a subset of women undergoing Caesarean section.date_rangeTime Frame:At delivery
- Placental tissue metabolomic analysisSample 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).date_rangeTime Frame:At delivery
- Blood, cord blood and placental 8-isoprostaneSample evaluations in a subset of women undergoing Caesarean section.date_rangeTime Frame:At delivery
- Blood, cord blood and placental reactive oxygen metabolites (ROMs) concentrations %Sample evaluations in a subset of women undergoing Caesarean section.date_rangeTime Frame:At delivery
- Number of Adverse Events (AEs)date_rangeTime Frame:Within 7 days after Delivery
- Severity of AEsdate_rangeTime Frame:Within 7 days after Delivery
- AE relationship to the investigational productdate_rangeTime Frame:Within 7 days after Delivery
Trial design
Trial Type
InterventionalIntervention Type
Dietary SupplementTrial Purpose
Supportive CareAllocation
RandomizedBlinding
N/AAssignment
Parallel AssignmentTrial Arms
2