AnaemiaNCT02190565
Safety and Efficacy Study of a Food Supplement for Pregnant and Lactating Women
A study testing Food supplement in people with Anaemia, run by Oriflame Cosmetics AB at 1 site in Sweden.
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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anaemia
- What is being tested?
- Food supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteSweden
- Study dates
- 7 Apr 2018to 7 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Woman and Child Health, Division of Obstetrics and Gynecology, Karolinska Institutet
Stockholm, SE-171 76
About this study
Official title: 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.
Read the 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.
- Conditions
- Anaemia
- Being tested
- Food supplement
- Keywords
- pregnancy, lactation, food supplement, anaemia
- Medical subject headings
- Anemia, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food supplementDietary supplement
Also called WellnessPack mama
Randomized double-blind, placebo-controlled
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo consisting of two sham multivitamin and mineral tablets and two capsules of oil Receives: 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 Receives: Dietary Supplement: Food supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: pregnancy week 28-30
Secondary outcomes (1)
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.
Measured: 6-10 weeks after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study start7 Apr 2018
- Primary completion7 Apr 2018
- Study completion7 Apr 2018
Why it stopped: Business decision - strategy changes and budget limitations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnaemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oriflame Cosmetics AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Karolinska Institutet
- Responsible party
- Sponsor
- Investigators
- Angelica Lindén Hirschberg, Professor, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02190565
- Sponsor's protocol ID
- 2014/815-31/4
- Status last verified
- Dec 2018
- First submitted
- 9 Jul 2014
- Last updated
- 5 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 23746776Kawai 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.
PubMed 21673856
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplementation With WellnessPack Mama During Pregnancy and Lactation - a Randomized Double-blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT02190565
- Acronym / sponsor ID
- 2014/815-31/4
- Conditions
- Anaemia
- Keywords
- pregnancy, lactation, food supplement, anaemia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business decision - strategy changes and budget limitations
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Oriflame Cosmetics ABIndustry (pharma, biotech, devices)
- Collaborators
- Karolinska Institutet
- Study start
- 7 Apr 2018 (actual)
- Primary completion
- 7 Apr 2018 (actual)
- Study completion
- 7 Apr 2018 (actual)
- First posted
- 15 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Food supplementPlacebo consisting of two sham multivitamin and mineral tablets and two capsules of oil |
| Food supplement | Active comparator | Dietary Supplement: Food supplementFood supplement consisting of fish oil (omega 3 fatty acids DHA and EPA) and multivitamin and mineral tablets with extra iron and folic acid |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food supplementAlso: WellnessPack mamaRandomized double-blind, placebo-controlled | Dietary supplement | Food supplement, Placebo |
Primary outcome
Prevalence of anaemia in active and placebo groups
Time frame: pregnancy week 28-30
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.
1 secondary outcome
Levels of nutritional biomarkers in maternal blood and breast milk
Time frame: 6-10 weeks after delivery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2018.
- Background: PubMed 23746776Bhutta 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.
- Background: PubMed 21673856Kawai 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.
- World Health Organization. Worldwide prevalence of anaemia 1993-2005: WHO Global Database on Anaemia.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angelica Lindén Hirschberg, Professor principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food supplement in people with Anaemia, run by Oriflame Cosmetics AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of anaemia in active and placebo groups (time frame: pregnancy week 28-30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02190565, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2018.