Clinical trial NCT04438928: 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
Official title: Effects of Multiple Micronutrients and Docosahexaenoic Acid (DHA) Supplementation During Pregnancy on Maternal Biomarkers and Infant Anthropometric Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Pregnant Women
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2020-06-19
Enrollment: 164
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Change from baseline: Blood RBC DHA/wt% TFA
timeFrame: Baseline: Screening at gestational age (GA) week 11 to 13 and at GA week 24 to 26 and week 34 to 36
Secondary outcomes:
measure: Change from baseline: Blood RBC EPA/wt% TFA
timeFrame: Baseline: Screening at gestational age (GA) week 11 to 13 and at GA week 24 to 26 and week 34 to 36
measure: Change from baseline: Blood RBC DHA/TFA ratio %
timeFrame: Baseline: Screening at gestational age (GA) week 11 to 13 and at GA week 24 to 26 and week 34 to 36
measure: Change from baseline: Blood RBC Omega 3 index in RBC
timeFrame: Baseline: Screening at gestational age (GA) week 11 to 13 and at GA week 24 to 26 and week 34 to 36
measure: Change from baseline: Blood 25-hydroxyvitamin D concentration %
timeFrame: Baseline: Screening at gestational age (GA) week 11 to 13 and at GA week 24 to 26 and week 34 to 36
measure: Change from baseline: Blood Glutathione (GSH)/oxidized Glutathione (GSSG) ratio %
timeFrame: Baseline: Screening at gestational age (GA) week 11 to 13 and at GA week 24 to 26 and week 34 to 36
measure: Change from baseline: Blood Reactive oxygen metabolites (ROMs) concentrations %
timeFrame: Baseline: Screening at gestational age (GA) week 11 to 13 and at GA week 24 to 26 and week 34 to 36
measure: Change from baseline: Blood 8-Isoprostane concentration %
timeFrame: Baseline: Screening at gestational age (GA) week 11 to 13 and at GA week 24 to 26 and week 34 to 36
measure: Infant sex
timeFrame: At delivery
measure: Infant gestational age
timeFrame: At delivery
measure: Infant head circumference
timeFrame: At delivery
measure: Infant weight measurements
timeFrame: At delivery
measure: Infant length measurements
timeFrame: At delivery
measure: Infant ponderal index
timeFrame: At delivery
measure: Infant skinfold thickness
timeFrame: At delivery
measure: Infant Apgar score
timeFrame: At delivery
measure: Infant bone density
timeFrame: Up to 10 days after delivery
measure: Umbilical cord blood gas analysis
timeFrame: At delivery
measure: Umbilical cord blood pH analysis
timeFrame: At delivery
measure: Cord blood metabolomic analysis
timeFrame: At delivery
measure: Placental weight
timeFrame: At delivery
measure: Placental biometric parameters
timeFrame: At delivery
measure: Blood, cord blood and placental RBC DHA/wt% TFA
timeFrame: At delivery
measure: Blood, cord blood and placental RBC EPA wt% TFA
timeFrame: At delivery
measure: Blood, cord blood and placental DHA/TFA ratio %
timeFrame: At delivery
measure: Blood, cord blood and placental RBC Omega 3 index
timeFrame: At delivery
measure: Mitochondrial DNA content evaluation in placental tissue and isolated trophoblast cells
timeFrame: At delivery
measure: IL-6 (Interleukin 6), IL-10 (Interleukin 10) and TNF-α (Tumor Necrosis Factor Alpha) in placental tissue and isolated trophoblast cells
timeFrame: At delivery
measure: Placental tissue metabolomic analysis
timeFrame: At delivery
measure: Blood, cord blood and placental 8-isoprostane
timeFrame: At delivery
measure: Blood, cord blood and placental reactive oxygen metabolites (ROMs) concentrations %
timeFrame: At delivery
measure: Number of Adverse Events (AEs)
timeFrame: Within 7 days after Delivery
measure: Severity of AEs
timeFrame: Within 7 days after Delivery
measure: AE relationship to the investigational product
timeFrame: Within 7 days after Delivery
Other outcomes:
measure: Maternal Food Frequency Questionnaire FFQ
timeFrame: Up to GA week 34-36
Locations:
city: Milano
country: Italy
facility: ASST Fatebenefratelli Sacco
state: Lombardia
city: Milano
country: Italy
facility: ASST Fatebenefratelli Sacco
state: Lombardia
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: