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

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.

Study Overview

• Status: Withdrawn
• Conditions: Anaemia
• Intervention / Treatment: Dietary supplement: Food supplement

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, SE-171 76
    • Department of Woman and Child Health, Division of Obstetrics and Gynecology, Karolinska Institutet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo consisting of two sham multivitamin and mineral tablets and two capsules of oil	Dietary supplement: Food supplement; Randomized double-blind, placebo-controlled; Other Names: WellnessPack mama
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	Dietary supplement: Food supplement; Randomized double-blind, placebo-controlled; Other Names: WellnessPack mama

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Oriflame Cosmetics AB
• Collaborators: Karolinska Institutet
• Investigators: Principal Investigator: Angelica Lindén Hirschberg, Professor, Karolinska Institutet, Stockholm, Sweden

Publications and helpful links

General Publications

• 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. Erratum In: Lancet. 2013 Aug 3;382(9890):396.
• 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.

Helpful Links

• Commission regulation (EU) No 440/2011 of 6 May 2011 on the authorisation and refusal of authorisation of certain health claims made on foods and referring to children's development and health.
• Commission regulation (EU) No 432/2012 of 16 May 2012 establishing a list of permitted health claims made on foods, other than those referring to the reduction of disease risk and to children's development and health.
• World Health Organization. Worldwide prevalence of anaemia 1993-2005: WHO Global Database on Anaemia.

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2018
• Primary Completion (Actual): April 7, 2018
• Study Completion (Actual): April 7, 2018

Study Registration Dates

• First Submitted: July 9, 2014
• First Submitted That Met QC Criteria: July 11, 2014
• First Posted (Estimate): July 15, 2014

Study Record Updates

• Last Update Posted (Actual): December 5, 2018
• Last Update Submitted That Met QC Criteria: December 3, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: pregnancy, lactation, food supplement, anaemia
• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia
• Other Study ID Numbers: 2014/815-31/4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No