Status:
COMPLETED
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
Lead Sponsor:
Bayer
Conditions:
Healthy Pregnant Women
Eligibility:
FEMALE
18-42 years
Phase:
NA
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 o...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 27 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 5 2019
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT04438928
Start Date
September 27 2016
End Date
December 5 2019
Last Update
November 16 2020
Active Locations (2)
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1
ASST Fatebenefratelli Sacco
Milan, Lombardy, Italy, 20154
2
ASST Fatebenefratelli Sacco
Milan, Lombardy, Italy, 20157