Safety and Efficacy Study of a Food Supplement for Pregnant and Lactating Women

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Supplementation With WellnessPack Mama During Pregnancy and Lactation - a Randomized Double-blind, Placebo-controlled Study

Conditions
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Anaemia

Intervention / Treatment
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* Dietary Supplement: Food supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Women below the age of 18 or above 40 years old. Women with a BMI below 18.5 or above 35 kg/m2. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo consisting of two sham multivitamin and mineral tablets and two capsules of oil | Dietary Supplement: Food supplement<br>* Randomized double-blind, placebo-controlled<br>* Other names: WellnessPack mama;|
| Active Comparator: Food supplement<br>Food supplement consisting of fish oil (omega 3 fatty acids DHA and EPA) and multivitamin and mineral tablets with extra iron and folic acid | Dietary Supplement: Food supplement<br>* Randomized double-blind, placebo-controlled<br>* Other names: WellnessPack mama;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of anaemia in active and placebo groups | 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. | pregnancy week 28-30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of nutritional biomarkers in maternal blood and breast milk | Levels of nutritional biomarkers such as DHA and vitamin D in maternal blood and breast milk will be measured in active and placebo groups. | 6-10 weeks after delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pregnancy, lactation, food supplement, anaemia