Effects of Multiple Micronutrients and Docosahexaenoic Acid (DHA) Supplementation During Pregnancy on Maternal Biomarkers and Infant Anthropometric Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 164
- 试验地点
- 2
- 主要终点
- Change from baseline: Blood RBC DHA/wt% TFA
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Healthy pregnant women - Supplement
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)]
干预措施: Elevit Pregnancy 2nd & 3rd Trimester (Dietary Supplement)
Healthy pregnant women - Non-Supplement
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)]
干预措施: Non-Supplement (Other)
结局指标
主要结局
Change from baseline: Blood RBC DHA/wt% TFA
时间窗: Baseline: Screening at gestational age (GA) week 11 to 13 and at GA week 24 to 26 and week 34 to 36
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.
次要结局
- Infant gestational age(At delivery)
- Severity of AEs(Within 7 days after Delivery)
- Infant sex(At delivery)
- 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)
- Infant head circumference(At delivery)
- 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 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)
- Infant bone density(Up to 10 days after delivery)
- Umbilical cord blood gas analysis(At delivery)
- Blood, cord blood and placental reactive oxygen metabolites (ROMs) concentrations %(At delivery)
- 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 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)
- Blood, cord blood and placental RBC DHA/wt% TFA(At delivery)
- 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 weight measurements(At delivery)
- Infant skinfold thickness(At delivery)
- Placental weight(At delivery)
- Number of Adverse Events (AEs)(Within 7 days after Delivery)
- Umbilical cord blood pH analysis(At delivery)
- Cord blood metabolomic analysis(At delivery)
- Blood, cord blood and placental RBC EPA wt% TFA(At delivery)
- Blood, cord blood and placental DHA/TFA ratio %(At delivery)
- Placental tissue metabolomic analysis(At delivery)
- Infant length measurements(At delivery)
- Infant ponderal index(At delivery)
- Infant Apgar score(At delivery)
- Placental biometric parameters(At delivery)
- Blood, cord blood and placental RBC Omega 3 index(At delivery)
- Mitochondrial DNA content evaluation in placental tissue and isolated trophoblast cells(At delivery)
- Blood, cord blood and placental 8-isoprostane(At delivery)
- AE relationship to the investigational product(Within 7 days after Delivery)
- IL-6 (Interleukin 6), IL-10 (Interleukin 10) and TNF-α (Tumor Necrosis Factor Alpha) in placental tissue and isolated trophoblast cells(At delivery)