Hirschberg 2014

Trial name or title	Protocol identifier: NCT02190565. Supplementation with WellnessPack mama during pregnancy and lactation ‐ a randomized double‐blind, placebo‐controlled study.
Methods	Parallel randomised, double‐blind trial investigating food supplementation for the primary prevention of anaemia.
Participants	Inclusion criteria: Healthy pregnant women aged 18‐40 years with a body mass index (BMI) above 18.5 and below 30 kg/m2 who visit prenatal 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 30 kg/m2. Women with any form of anaemia as diagnosed at the first visit to the prenatal clinic. Women expecting 2 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 participant is excluded from the study.
Interventions	Placebo comparator: placebo. Placebo consisting of 2 sham multivitamin and mineral tablets and 2 capsules of oil. Active comparator: 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. Intervention: Dietary Supplement: Food supplement.
Outcomes	Primary outcome: prevalence of anaemia in active and placebo groups [Time Frame: pregnancy weeks 28‐30] [Designated as safety issue: No] Blood will be analysed for Hb 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. Secondary outcome: Levels of nutritional biomarkers in maternal blood and breast milk [Time Frame: 6‐10 weeks after delivery] [ Designated as safety issue: No] Levels of nutritional biomarkers such as DHA and vitamin D in maternal blood and breast milk will be measured in active and placebo groups.
Starting date	October 2014 ‐ January 2016.
Contact information	Professor Angelica Lindén Hirschberg: Angelica.Hirschberg.Linden@ki.se
Notes	Sudy sponsor: Oriflame Cosmetics AB. Collaborators: Karonlinska Institutet.