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

NCT02190565 | Withdrawn

• 1 other identifier: 2014/815-31/4
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Anaemia

Keywords

pregnancy, lactation, food supplement, anaemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Levels of nutritional biomarkers in maternal blood and breast milk

  6-10 weeks after delivery

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Food supplement

Food supplement

ACTIVE COMPARATOR

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

Interventions

Food supplement DIETARY_SUPPLEMENT

Randomized double-blind, placebo-controlled

Also known as: WellnessPack mama

Food supplement; Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oriflame Cosmetics AB: lead
• Karolinska Institutet: collaborator

Study Sites (1)

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

Stockholm, SE-171 76, Sweden

Location

Related Publications (2)

• 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.

  PMID: 23746776 BACKGROUND

• 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.

  PMID: 21673856 BACKGROUND

Related Links

• World Health Organization. Worldwide prevalence of anaemia 1993-2005: WHO Global Database on Anaemia.

MeSH Terms

Conditions

Anemia; Breast Feeding

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Angelica Lindén Hirschberg, Professor

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2014
• First Posted: July 15, 2014
• Study Start: April 7, 2018
• Primary Completion: April 7, 2018
• Study Completion: April 7, 2018
• Last Updated: December 5, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)