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

Primary Purpose

Anaemia

Status
Withdrawn
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Food supplement
Sponsored by
Oriflame Cosmetics AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anaemia focused on measuring pregnancy, lactation, food supplement, anaemia

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Department of Woman and Child Health, Division of Obstetrics and Gynecology, Karolinska Institutet

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Food supplement

Arm Description

Placebo consisting of two sham multivitamin and mineral tablets and two capsules of oil

Food supplement consisting of fish oil (omega 3 fatty acids DHA and EPA) and multivitamin and mineral tablets with extra iron and folic acid

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 9, 2014
Last Updated
December 3, 2018
Sponsor
Oriflame Cosmetics AB
Collaborators
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT02190565
Brief Title
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

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Business decision - strategy changes and budget limitations
Study Start Date
April 7, 2018 (Actual)
Primary Completion Date
April 7, 2018 (Actual)
Study Completion Date
April 7, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oriflame Cosmetics AB
Collaborators
Karolinska Institutet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anaemia
Keywords
pregnancy, lactation, food supplement, anaemia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo consisting of two sham multivitamin and mineral tablets and two capsules of oil
Arm Title
Food supplement
Arm Type
Active Comparator
Arm Description
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 Type
Dietary Supplement
Intervention Name(s)
Food supplement
Other Intervention Name(s)
WellnessPack mama
Intervention Description
Randomized double-blind, placebo-controlled
Primary Outcome Measure Information:
Title
Prevalence of anaemia in active and placebo groups
Description
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.
Time Frame
pregnancy week 28-30
Secondary Outcome Measure Information:
Title
Levels of nutritional biomarkers in maternal blood and breast milk
Description
Levels of nutritional biomarkers such as DHA and vitamin D in maternal blood and breast milk will be measured in active and placebo groups.
Time Frame
6-10 weeks after delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angelica Lindén Hirschberg, Professor
Organizational Affiliation
Karolinska Institutet, Stockholm, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Woman and Child Health, Division of Obstetrics and Gynecology, Karolinska Institutet
City
Stockholm
ZIP/Postal Code
SE-171 76
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23746776
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. Erratum In: Lancet. 2013 Aug 3;382(9890):396.
Results Reference
background
PubMed Identifier
21673856
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.
Results Reference
background
Links:
URL
http://whqlibdoc.who.int/publications/2008/9789241596657_eng.pdf
Description
World Health Organization. Worldwide prevalence of anaemia 1993-2005: WHO Global Database on Anaemia.

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

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