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

Anaemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02190565
• Other study ID #: 2014/815-31/4
• Status: Withdrawn
• Phase: N/A
• Start date: April 7, 2018
• Est. completion date: April 7, 2018

Study information

• Verified date: December 2018
• Source: Oriflame Cosmetics AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 7, 2018
• Est. primary completion date: April 7, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anaemia

Intervention

Dietary Supplement:
• Food supplement
Randomized double-blind, placebo-controlled

Locations

Country	Name	City	State
Sweden	Department of Woman and Child Health, Division of Obstetrics and Gynecology, Karolinska Institutet	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Oriflame Cosmetics AB	Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

References & 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. Review. Erratum in: Lancet. 2013 Aug 3;382(9890):396. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   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.
•   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.
•   World Health Organization, Food and Agricultural Organization of the United Nations. Vitamin and mineral requirements in human nutrition, 2nd edition. 2004.
•   World Health Organization. Worldwide prevalence of anaemia 1993-2005: WHO Global Database on Anaemia.