Clinical trial NCT02190565: Safety and Efficacy Study of a Food Supplement for Pregnant and Lactating Women
Official title: Supplementation With WellnessPack Mama During Pregnancy and Lactation - a Randomized Double-blind, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Anaemia
Keywords: pregnancy, lactation, food supplement, anaemia
Lead sponsor: Oriflame Cosmetics AB
Sponsor class: INDUSTRY
Collaborators: name: Karolinska Institutet
First posted: 2014-07-15
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence of anaemia in active and placebo groups
timeFrame: pregnancy week 28-30
Secondary outcomes:
measure: Levels of nutritional biomarkers in maternal blood and breast milk
timeFrame: 6-10 weeks after delivery
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Department of Woman and Child Health, Division of Obstetrics and Gynecology, Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Angelica Lindén Hirschberg, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bhutta ZA, Das JK, Rizvi A, Gaffey MF, Walker N, Horton S, Webb P, Lartey A, Black RE; Lancet Nutrition Interventions Review Group, the Maternal and Child Nutrition Study Group. Evidence-based interventions for improvement of maternal and child nutrition: what can be done and at what cost? Lancet. 2013 Aug 3;382(9890):452-477. doi: 10.1016/S0140-6736(13)60996-4. Epub 2013 Jun 6.
citation: Kawai K, Spiegelman D, Shankar AH, Fawzi WW. Maternal multiple micronutrient supplementation and pregnancy outcomes in developing countries: meta-analysis and meta-regression. Bull World Health Organ. 2011 Jun 1;89(6):402-411B. doi: 10.2471/BLT.10.083758. Epub 2011 Mar 21.