Supplementation With WellnessPack Mama During Pregnancy and Lactation - a Randomized Double-blind, Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Prevalence of anaemia in active and placebo groups
研究概览
简要总结
The purpose of this study is to determine whether a food supplement consisting of vitamins, minerals and fish oil taken during and after pregnancy can decrease the need for additional iron supplementation due to anemia during pregnancy, and optimize levels of nutritional markers such as vitamin D and docosahexaenoic acid (DHA, an omega 3 fatty acid) in maternal blood and breast milk, compared to placebo.
详细描述
200 healthy, pregnant women will be randomized to receive either active or placebo at their first visit to the pre-natal centres. They will be monitored at regular intervals, blood samples will be taken and they will be asked about compliance and any adverse reactions.
Approx 8 weeks after delivery, the women will come to the pre-natal centres for a check-up. During this visit, a blood sample will be drawn and a breast milk sample will be collected.
The blood samples will be analysed for haemoglobin, serum ferritin, vitamin D and DHA. The breast milk samples will be analysed for vitamin D and DHA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy pregnant women aged 18-40 years with a body mass index (BMI) above 18.5 and below 35 kg/m2 who visit pre-natal clinics (midwife centres) to register.
- •Nulliparous and multiparous women.
- •The women must be able to understand verbal and written information in Swedish to give an informed consent to participate in the study.
排除标准
- •Women below the age of 18 or above 40 years old.
- •Women with a BMI below 18.5 or above 35 kg/m
- •Women with any form of anaemia as diagnosed at the first visit to the prenatal clinic.
- •Women expecting two or more babies.
- •Women who have undergone bariatric surgery.
- •Women on medication with pharmaceuticals that could affect the result of the study, e.g., vitamin K antagonists.
- •Women who are allergic to any of the components of WellnessPack mama, e.g., fish.
- •Women who suffer from drug or alcohol abuse.
- •Women who suffer from known severe eating disorders.
- •Women who suffer from chronic diseases that could affect gastrointestinal absorption and metabolism.
- •Women who want to continue or start using similar food supplements in addition to WellnessPack mama/placebo, unless recommended by a physician or midwife, will be excluded from the study.
- •Upon miscarriage or transfer to prenatal care specialist, the subject is excluded from the study.
研究组 & 干预措施
Placebo
Placebo consisting of two sham multivitamin and mineral tablets and two capsules of oil
干预措施: Food supplement (Dietary Supplement)
Food supplement
Food supplement consisting of fish oil (omega 3 fatty acids DHA and EPA) and multivitamin and mineral tablets with extra iron and folic acid
干预措施: Food supplement (Dietary Supplement)
结局指标
主要结局
Prevalence of anaemia in active and placebo groups
时间窗: pregnancy week 28-30
Blood will be analysed for haemoglobin and ferritin values. We will compare how many women in each group (active vs placebo) are ordinated iron supplementation due to anaemia by mid-pregnancy.
次要结局
- Levels of nutritional biomarkers in maternal blood and breast milk(6-10 weeks after delivery)