Status:
WITHDRAWN
Safety and Efficacy Study of a Food Supplement for Pregnant and Lactating Women
Lead Sponsor:
Oriflame Cosmetics AB
Collaborating Sponsors:
Karolinska Institutet
Conditions:
Anaemia
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief Summary
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 supplementa...
Detailed Description
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 tak...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 7 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02190565
Start Date
April 7 2018
End Date
April 7 2018
Last Update
December 5 2018
Active Locations (1)
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1
Department of Woman and Child Health, Division of Obstetrics and Gynecology, Karolinska Institutet
Stockholm, Sweden, SE-171 76