Healthy Pregnant WomenNCT04438928
Clinical Study on the Effect of Elevit Pregnancy 2nd & 3rd Trimester (Multi-micronutrients & DHA Supplement) on the Nutritional Status of Pregnant Women During Second and Third Trimester
A study testing Elevit Pregnancy 2nd & 3rd Trimester and Non-Supplement in people with Healthy Pregnant Women, run by Bayer at 2 sites in Italy.
Trial summary
The aim of this study is to collect information how adding a soft gel preparation of micronutrients such as vitamins, dietary minerals plus omega-3 fatty acid (docosahexaenoic acid, DHA) to the diet of pregnant women during the 2nd and 3rd trimesters of pregnancy effects the nutritional state of the mother and infants… Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Pregnant Women
- What is being tested?
- Elevit Pregnancy 2nd & 3rd Trimester and Non-Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 2 sitesItaly
- Study dates
- 27 Sep 2016to 5 Dec 2019
- 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 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy pregnant Caucasian women aged 18 to 42 years (inclusive) in their 1st - 2nd trimester (gestational age (GA) week 11-14 at screening);
- Hemoglobin (Hg) > 105g/L;
- Inconspicuous fetal anomaly screening;
- Normal ultrasound examination (Ultra Sonography (USG));
- Singleton pregnancy;
- Taking at least 400 mcg folate per day;
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- Seronegative for Human Immunodeficiency Virus (HIV), Hepatitis B and Hepatitis C at screening;
- Pregnant women who, in the opinion of the Investigator, are willing and able to participate in all scheduled visits, to adhere to the supplementation plan, to laboratory tests and to all other study related procedures according to the clinical protocol;
- Pregnant women providing a personally signed and dated given informed consent to participate in the study and to adhere to all study procedures indicating that they have been informed of all pertinent aspects of the trial and that they understood and accepted these, prior to admission to the study.
Who cannot join
- Physical (including vital signs e.g. blood pressure and pulse rate), hematological and clinical-chemical parameters deviating from normal and with clinical relevance;
- Any infection (acute or chronic) at screening and baseline;
- Any current metabolic diseases (e.g. diabetes, hypothyroidism);
- Less than 12 months from previous delivery;
- Any history or current diseases, which are associated with malabsorption, or other severe diseases of the gastrointestinal tract (e.g. chronic inflammatory bowel disease, iron accumulation, iron utilization disorders); Any history or current neurological, cardiac, endocrine or bleeding disorders;
- Specific diets (e.g. vegan vegetarian, celiac, lactose free);
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- Body mass index (BMI) < 18 or >30 kg/m2;
- Pregnant women already taking DHA/multivitamin supplements (except folate or iron);
- Diagnosed or suspected malignant or premalignant disease;
- Current clinically significant depression;
- Current intake of pharmaceuticals or dietary supplements which may interact with any of the ingredients of the trial treatment (i.e. fluoroquinolones, bisphosphonates, levodopa, levothyroxine, penicillamine, antibiotics containing tetracycline or trietine);
- History of or current diseases where vitamin, mineral, trace element or DHA supplementation might be not recommended /contraindicated [such as sickle cell anemia, copper metabolism disorders (Wilson's disease), renal disease, nephrolithiasis, urolithiasis, hypercalcemia, hypercalciuria, hepatobiliary diseases, existing hypervitaminosis, iron metabolism disorders, hypermagnesemia];
- Severe Hyperemesis gravidarum;
- Previous adverse birth outcomes (e.g. small for gestational age, low birth weight, premature birth, stillbirth, more than two consecutive spontaneous abortions);
- Previous adverse pregnancy outcomes (e.g. gestational diabetes);
- Diagnosed congenital abnormalities in current or previous pregnancy;
- Known carrier or affected with a genetic disease or condition (e.g. mutation carrier for autosomal recessive diseases);
- History of or current abuse of drugs, alcohol or other substances;
- Current smokers and women who smoked during current pregnancy;
- Any history of hypersensitivity or known allergy to any of the ingredients of the study supplement.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
ASST Fatebenefratelli Sacco
Milan, Lombardy, 20154
ASST Fatebenefratelli Sacco
Milan, Lombardy, 20157
About this study
Official title: Effects of Multiple Micronutrients and Docosahexaenoic Acid (DHA) Supplementation During Pregnancy on Maternal Biomarkers and Infant Anthropometric Outcomes
The aim of this study is to collect information how adding a soft gel preparation of micronutrients such as vitamins, dietary minerals plus omega-3 fatty acid (docosahexaenoic acid, DHA) to the diet of pregnant women during the 2nd and 3rd trimesters of pregnancy effects the nutritional state of the mother and infants at delivery.
- Conditions
- Healthy Pregnant Women
- Being tested
- Elevit Pregnancy 2nd & 3rd Trimester, Non-Supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elevit Pregnancy 2nd & 3rd TrimesterDietary supplement
Also called BAY 987765 Multi-micronutrient & DHA
Once daily micronutrient plus DHA supplementation (Multi-micronutrients and docosahexaenoic acid (MMS) soft gel capsules)
Non-SupplementOther
Control study group of pregnant women non-supplemented with multi-micronutrients and docosahexaenoic acid (MMS) soft gel capsules
| Study group | Role | What they receive |
|---|---|---|
| Healthy pregnant women - Supplement | Experimental | Supplementation with micronutrients plus docosahexaenoic acid (DHA) preparation (Multimicronutrients and docosahexaenoic acid (MMS) soft gel capsules) during 2nd and 3rd trimesters of pregnancy.
Subgroup: Healthy pregnant women with Caesarean section [A subset of subjects (approximately 10 subjects per study arm) undergoing elective Caesarean section (for reasons independent from the study)] Receives: Dietary Supplement: Elevit Pregnancy 2nd & 3rd Trimester |
| Healthy pregnant women - Non-Supplement | Other | Control study group
Subgroup: Healthy pregnant women with Caesarean section [A subset of subjects (approximately 10 subjects per study arm) undergoing elective Caesarean section (for reasons independent from the study)] Receives: Other: Non-Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline: Blood RBC DHA/wt% TFA
In order to assess the beneficial effects of supplementation with micronutrients and DHA (docosahexaenoic acid) during 2nd and 3rd trimesters of pregnancy, the red blood cell (RBC) DHA weight percent of total fatty acids (DHA wt% TFA) will be measured compared to baseline as primary maternal variable.
Gestational age is a measure of the age of a pregnancy which is taken from the beginning of the woman's last menstrual period (LMP), or the corresponding age of the gestation as estimated by a more accurate method if available. Such methods include adding 14 days to a known duration since fertilization (as is possible in in vitro fertilization), or by obstetric ultrasonography. The popularity of using such a definition of gestational age is that menstrual periods are essentially always noticed, while there is usually a lack of a convenient way to discern when fertilization occurred.
Measured: Baseline: Screening at gestational age (GA) week 11 to 13 and at GA week 24 to 26 and week 34 to 36
Secondary outcomes (33)
Change from baseline: Blood RBC EPA/wt% TFA
Red blood cell (RBC) EPA (eicosapentaenoic acid) weight percent of total fatty acids (DHA wt% TFA).
Measured: Baseline: Screening at gestational age (GA) week 11 to 13 and at GA week 24 to 26 and week 34 to 36
Change from baseline: Blood RBC DHA/TFA ratio %
Measured: Baseline: Screening at gestational age (GA) week 11 to 13 and at GA week 24 to 26 and week 34 to 36
Change from baseline: Blood RBC Omega 3 index in RBC
The "omega-3 index" reflects the content of EPA plus DHA in erythrocyte membranes expressed as a percentage of total erythrocyte fatty acids.
Measured: Baseline: Screening at gestational age (GA) week 11 to 13 and at GA week 24 to 26 and week 34 to 36
Change from baseline: Blood 25-hydroxyvitamin D concentration %
Measured: Baseline: Screening at gestational age (GA) week 11 to 13 and at GA week 24 to 26 and week 34 to 36
Change from baseline: Blood Glutathione (GSH)/oxidized Glutathione (GSSG) ratio %
Glutathione exists in reduced (GSH) and oxidized (GSSG) states. Reduced glutathione is the most abundant antioxidant in aerobic cells and participates in the detoxification of lipid hydroperoxides and hydrogen peroxide exerted by glutathione peroxidases. When cells are exposes to increased oxidative stress levels, GSSG accumulates and the GSH/GSSG ratio decreases.
Measured: Baseline: Screening at gestational age (GA) week 11 to 13 and at GA week 24 to 26 and week 34 to 36
Change from baseline: Blood Reactive oxygen metabolites (ROMs) concentrations %
Measured: Baseline: Screening at gestational age (GA) week 11 to 13 and at GA week 24 to 26 and week 34 to 36
Change from baseline: Blood 8-Isoprostane concentration %
Measured: Baseline: Screening at gestational age (GA) week 11 to 13 and at GA week 24 to 26 and week 34 to 36
Infant sex
Measured: At delivery
Infant gestational age
Measured: At delivery
Infant head circumference
Measured: At delivery
Infant weight measurements
Measured: At delivery
Infant length measurements
Measured: At delivery
Infant ponderal index
Measured: At delivery
Infant skinfold thickness
Triplicate measurements: triceps, biceps, suprailiac, and subscapular on left side with standard skinfold caliper operated with constant pressure of 10 g/mm2)
Measured: At delivery
Infant Apgar score
Measured: At delivery
Infant bone density
Measured: Up to 10 days after delivery
Umbilical cord blood gas analysis
Cord blood sample evaluations in a subset of women undergoing Caesarean section.
Measured: At delivery
Umbilical cord blood pH analysis
Cord blood sample evaluations in a subset of women undergoing Caesarean section.
Measured: At delivery
Cord blood metabolomic analysis
Cord blood sample evaluations in a subset of women undergoing Caesarean section.
Measured: At delivery
Placental weight
Placenta tissue sample evaluation in a subset of women undergoing caesarean section.
Placental efficiency will be estimated through the feto/placental weight (F/P) ratio, calculated as birth weight divided by the placental weight.
Measured: At delivery
Placental biometric parameters
Placenta tissue sample evaluation in a subset of women undergoing caesarean section.
i.e. larger (D) and smaller (d) diameters of the chorionic elliptical disc, feto/placental weight (F/P ratio)
Measured: At delivery
Blood, cord blood and placental RBC DHA/wt% TFA
Sample evaluations in a subset of women undergoing Caesarean section.
Measured: At delivery
Blood, cord blood and placental RBC EPA wt% TFA
Sample evaluations in a subset of women undergoing Caesarean section.
Measured: At delivery
Blood, cord blood and placental DHA/TFA ratio %
Sample evaluations in a subset of women undergoing Caesarean section.
Measured: At delivery
Blood, cord blood and placental RBC Omega 3 index
Sample evaluations in a subset of women undergoing Caesarean section.
Measured: At delivery
Mitochondrial DNA content evaluation in placental tissue and isolated trophoblast cells
mtDNA is a well-accepted molecular marker to assess mitochondria content.
Sample evaluations in a subset of women undergoing Caesarean section.
Measured: At delivery
IL-6 (Interleukin 6), IL-10 (Interleukin 10) and TNF-α (Tumor Necrosis Factor Alpha) in placental tissue and isolated trophoblast cells
These genes are constitutively expressed in human placenta and are a reliable marker of inflammation.
Sample evaluations in a subset of women undergoing Caesarean section.
Measured: At delivery
Placental tissue metabolomic analysis
Sample evaluations in a subset of women undergoing Caesarean section.
The rationale for conducting metabolomic analysis is to understand if multi-micronutrient supplement (MMS) supplementation during the second and third trimester of pregnancy influences maternal and infant gestational outcomes (e.g. oxidative stress, placental function).
Measured: At delivery
Blood, cord blood and placental 8-isoprostane
Sample evaluations in a subset of women undergoing Caesarean section.
Measured: At delivery
Blood, cord blood and placental reactive oxygen metabolites (ROMs) concentrations %
Sample evaluations in a subset of women undergoing Caesarean section.
Measured: At delivery
Number of Adverse Events (AEs)
Measured: Within 7 days after Delivery
Severity of AEs
Measured: Within 7 days after Delivery
AE relationship to the investigational product
Measured: Within 7 days after Delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start27 Sep 2016
- Primary completion5 Dec 2019
- Study completion5 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy Pregnant WomenStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04438928
- Sponsor's protocol ID
- 18366
- Status last verified
- Nov 2020
- First submitted
- 29 May 2020
- Last updated
- 16 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Parisi F, Mando C, Novielli C, Anelli GM, Cazzola R, Lisso F, Sarno L, Marelli E, Lubrano C, Maria Antonazzo PG, Cetin I. Maternal mid-pregnancy long-chain polyunsaturated fatty acid profile is associated with pregestational body mass index and neonatal anthropometric measures at birth among non-obese pregnancies: results from two Italian multicenter cohorts. Nutr Metab (Lond). 2025 Nov 12;22(1):137. doi: 10.1186/s12986-025-01034-8.
PubMed 41225593
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Multiple Micronutrients and Docosahexaenoic Acid (DHA) Supplementation During Pregnancy on Maternal Biomarkers and Infant Anthropometric Outcomes
- ClinicalTrials.gov ID
- NCT04438928
- Acronym / sponsor ID
- 18366
- Conditions
- Healthy Pregnant Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 27 Sep 2016 (actual)
- Primary completion
- 5 Dec 2019 (actual)
- Study completion
- 5 Dec 2019 (actual)
- First posted
- 19 Jun 2020 (actual)
- 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 aim of this study is to collect information how adding a soft gel preparation of micronutrients such as vitamins, dietary minerals plus omega-3 fatty acid (docosahexaenoic acid, DHA) to the diet of pregnant women during the 2nd and 3rd trimesters of pregnancy effects the nutritional state of the mother and infants at delivery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy pregnant women - Supplement | Experimental | Dietary Supplement: Elevit Pregnancy 2nd & 3rd TrimesterSupplementation with micronutrients plus docosahexaenoic acid (DHA) preparation (Multimicronutrients and docosahexaenoic acid (MMS) soft gel capsules) during 2nd and 3rd trimesters of pregnancy. Subgroup: Healthy pregnant women with Caesarean section [A subset of subjects (approximately 10 subjects per study arm) undergoing elective Caesarean section (for reasons independent from the study)] |
| Healthy pregnant women - Non-Supplement | Other | Other: Non-SupplementControl study group Subgroup: Healthy pregnant women with Caesarean section [A subset of subjects (approximately 10 subjects per study arm) undergoing elective Caesarean section (for reasons independent from the study)] |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy pregnant Caucasian women aged 18 to 42 years (inclusive) in their 1st - 2nd trimester (gestational age (GA) week 11-14 at screening);
- Hemoglobin (Hg) > 105g/L;
- Inconspicuous fetal anomaly screening;
- Normal ultrasound examination (Ultra Sonography (USG));
- Singleton pregnancy;
Key exclusion criteria (20 listed)
- Physical (including vital signs e.g. blood pressure and pulse rate), hematological and clinical-chemical parameters deviating from normal and with clinical relevance;
- Any infection (acute or chronic) at screening and baseline;
- Any current metabolic diseases (e.g. diabetes, hypothyroidism);
- Less than 12 months from previous delivery;
- Any history or current diseases, which are associated with malabsorption, or other severe diseases of the gastrointestinal tract (e.g. chronic inflammatory bowel disease, iron accumulation, iron utilization disorders); Any history or current neurological, cardiac, endocrine or bleeding disorders;
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 |
|---|---|---|
| Elevit Pregnancy 2nd & 3rd TrimesterAlso: BAY 987765 Multi-micronutrient & DHAOnce daily micronutrient plus DHA supplementation (Multi-micronutrients and docosahexaenoic acid (MMS) soft gel capsules) | Dietary supplement | Healthy pregnant women - Supplement |
| Non-SupplementControl study group of pregnant women non-supplemented with multi-micronutrients and docosahexaenoic acid (MMS) soft gel capsules | Other | Healthy pregnant women - Non-Supplement |
Primary outcome
Change from baseline: Blood RBC DHA/wt% TFA
Time frame: Baseline: Screening at gestational age (GA) week 11 to 13 and at GA week 24 to 26 and week 34 to 36
In order to assess the beneficial effects of supplementation with micronutrients and DHA (docosahexaenoic acid) during 2nd and 3rd trimesters of pregnancy, the red blood cell (RBC) DHA weight percent of total fatty acids (DHA wt% TFA) will be measured compared to baseline as primary maternal variable. Gestational age is a measure of the age of a pregnancy which is taken from the beginning of the woman's last menstrual period (LMP), or the corresponding age of the gestation as estimated by a more accurate method if available. Such methods include adding 14 days to a known duration since fertilization (as is possible in in vitro fertilization), or by obstetric ultrasonography. The popularity of using such a definition of gestational age is that menstrual periods are essentially always noticed, while there is usually a lack of a convenient way to discern when fertilization occurred.
33 secondary outcomes
Change from baseline: Blood RBC EPA/wt% TFA
Time frame: Baseline: Screening at gestational age (GA) week 11 to 13 and at GA week 24 to 26 and week 34 to 36
Change from baseline: Blood RBC DHA/TFA ratio %
Time frame: Baseline: Screening at gestational age (GA) week 11 to 13 and at GA week 24 to 26 and week 34 to 36
Change from baseline: Blood RBC Omega 3 index in RBC
Time frame: Baseline: Screening at gestational age (GA) week 11 to 13 and at GA week 24 to 26 and week 34 to 36
Change from baseline: Blood 25-hydroxyvitamin D concentration %
Time frame: Baseline: Screening at gestational age (GA) week 11 to 13 and at GA week 24 to 26 and week 34 to 36
Change from baseline: Blood Glutathione (GSH)/oxidized Glutathione (GSSG) ratio %
Time frame: Baseline: Screening at gestational age (GA) week 11 to 13 and at GA week 24 to 26 and week 34 to 36
Change from baseline: Blood Reactive oxygen metabolites (ROMs) concentrations %
Time frame: Baseline: Screening at gestational age (GA) week 11 to 13 and at GA week 24 to 26 and week 34 to 36
Change from baseline: Blood 8-Isoprostane concentration %
Time frame: Baseline: Screening at gestational age (GA) week 11 to 13 and at GA week 24 to 26 and week 34 to 36
Infant sex
Time frame: At delivery
Infant gestational age
Time frame: At delivery
Infant head circumference
Time frame: At delivery
Infant weight measurements
Time frame: At delivery
Infant length measurements
Time frame: At delivery
Infant ponderal index
Time frame: At delivery
Infant skinfold thickness
Time frame: At delivery
Infant Apgar score
Time frame: At delivery
Infant bone density
Time frame: Up to 10 days after delivery
Umbilical cord blood gas analysis
Time frame: At delivery
Umbilical cord blood pH analysis
Time frame: At delivery
Cord blood metabolomic analysis
Time frame: At delivery
Placental weight
Time frame: At delivery
Placental biometric parameters
Time frame: At delivery
Blood, cord blood and placental RBC DHA/wt% TFA
Time frame: At delivery
Blood, cord blood and placental RBC EPA wt% TFA
Time frame: At delivery
Blood, cord blood and placental DHA/TFA ratio %
Time frame: At delivery
Blood, cord blood and placental RBC Omega 3 index
Time frame: At delivery
Mitochondrial DNA content evaluation in placental tissue and isolated trophoblast cells
Time frame: At delivery
IL-6 (Interleukin 6), IL-10 (Interleukin 10) and TNF-α (Tumor Necrosis Factor Alpha) in placental tissue and isolated trophoblast cells
Time frame: At delivery
Placental tissue metabolomic analysis
Time frame: At delivery
Blood, cord blood and placental 8-isoprostane
Time frame: At delivery
Blood, cord blood and placental reactive oxygen metabolites (ROMs) concentrations %
Time frame: At delivery
Number of Adverse Events (AEs)
Time frame: Within 7 days after Delivery
Severity of AEs
Time frame: Within 7 days after Delivery
AE relationship to the investigational product
Time frame: Within 7 days after Delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
- Derived from this study: PubMed 41225593Parisi F, Mando C, Novielli C, Anelli GM, Cazzola R, Lisso F, Sarno L, Marelli E, Lubrano C, Maria Antonazzo PG, Cetin I. Maternal mid-pregnancy long-chain polyunsaturated fatty acid profile is associated with pregestational body mass index and neonatal anthropometric measures at birth among non-obese pregnancies: results from two Italian multicenter cohorts. Nutr Metab (Lond). 2025 Nov 12;22(1):137. doi: 10.1186/s12986-025-01034-8.
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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.
Bayer Study Director study director
Bayer
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elevit Pregnancy 2nd & 3rd Trimester and Non-Supplement in people with Healthy Pregnant Women, run by Bayer at 2 sites in Italy.
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 9 inclusion and 20 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: finished, as of the sponsor's last update on 16 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline: Blood RBC DHA/wt% TFA (time frame: Baseline: Screening at gestational age (GA) week 11 to 13 and at GA week 24 to 26 and week 34 to 36). 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 NCT04438928, which also lists 1 linked publication.
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 16 Nov 2020.