NCT02190565

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

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Oriflame Cosmetics AB · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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 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

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.

Conditions

• Anaemia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Food supplement	Randomized double-blind, placebo-controlled

Timeline

• Start date: 2018-04-07
• Primary completion: 2018-04-07
• Completion: 2018-04-07
• First posted: 2014-07-15
• Last updated: 2018-12-05

Locations

1 site across 1 country: Sweden