Iron-deficiency AnemiaNCT03122938
Lactoferrin Supplementation and Iron Metabolism in Healthy Pregnant Women
A study testing lactoferrin-supplemented formula and formula without lactoferrin supplementation in people with Iron-deficiency Anemia, run by Beingmate Baby & Child Food Co Ltd . at 1 site in China.
Trial summary
To assess the effects of a lactoferrin supplemented formula on fetal development , iron metabolism and immunity in healthy pregnant women. One hundred and twenty healthy pregnant women (24<gestational weeks<26) are enrolled and randomly assigned to lactoferrin-supplemented formula group (active group) or normal… Read more about this study
- Who is it for?
- Ages 20 to 34 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron-deficiency Anemia
- What is being tested?
- lactoferrin-supplemented formula and formula without lactoferrin supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Apr 2016to May 2017
- 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 20 to 34 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy pregnant women with gestational weeks between 24 and 26;
- with hemoglobin concentration > 110g / L;
- without indication of abortion;
- without infectious disease or hereditary disease;
- without iron supplementation before enrollment.
Who cannot join
- with red blood count <3.5*10^12/L，hemoglobin concentration<110g/L or serum ferritin <20 μg/L；
- diagnosed with gestational diabetes mellitus;
- enrolled in other intervention study within past 1 month.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Daily Bovine Lactoferrin Supplementation on Fetal Development and Iron Metabolism in Healthy Pregnant Women: A Randomized Double-blind Controlled Trial
To assess the effects of a lactoferrin supplemented formula on fetal development , iron metabolism and immunity in healthy pregnant women. One hundred and twenty healthy pregnant women (24<gestational weeks<26) are enrolled and randomly assigned to lactoferrin-supplemented formula group (active group) or normal formula group (control group, without lactoferrin supplementation). Subjects allocated in active group consume lactoferrin supplemented formula (85mg lactoferrin per 100g) 3 times a day (81g totally), while those in control group consume formula without lactoferrin supplementation (<6mg lactoferrin per 100g formula) according to the same schedule. Routine blood test including hemoglobin and serum ferritin, and food frequency questionnaire-based review and 24h*3 dietary record are performed every 4 weeks during intervention until delivery. Body weight of newborns are recorded after delivery. The differences in iron deficiency anemia morbility of pregnant women and anthropometric measurements of newborns between groups would be analyzed after completion of this study.
- Conditions
- Iron-deficiency Anemia
- Being tested
- lactoferrin-supplemented formula, formula without lactoferrin supplementation
- Keywords
- lactoferrin, Iron Metabolism, iron-deficiency anemia, pregnant women, fetal development
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lactoferrin-supplemented formulaDietary supplement
Also called Beingmate Nursing Mommy Formula
Subjects consume lactoferrin-supplemented formula (85mg lactoferrin per 100g) 3 times a day (81g totally).
formula without lactoferrin supplementationDietary supplement
Also called Beingmate Nursing Mommy Formula
Subjects consume formula without lactoferrin supplementation (<6mg lactoferrin per 100g formula) 3 times a day (81g totally).
| Study group | Role | What they receive |
|---|---|---|
| Lactoferrin Group | Experimental | lactoferrin-supplemented formula Receives: Dietary Supplement: lactoferrin-supplemented formula |
| Control Group | Placebo comparator | formula without lactoferrin supplementation Receives: Dietary Supplement: formula without lactoferrin supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
iron-deficiency anemia morbility of pregnant women
Measured: every 4 weeks during intervention, namely 28th gestational weeks, 32nd gestational weeks, 36th gestational weeks and the day of delivery.
Secondary outcomes (4)
iron metabolism of pregnant women
hemoglobin concentration and serum ferritin concentration
Measured: every 4 weeks during intervention, namely 28th gestational weeks, 32nd gestational weeks, 36th gestational weeks and the day of delivery.
fetal growth
body weight of newborns
Measured: the day of delivery, recorded by nurse.
fetal growth and development
body length of newborns
Measured: the day of delivery,recorded by nurse immediately
fetal development
head circumference
Measured: the day of delivery, measured and recorded by nurse.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study startApr 2016
- Primary completionApr 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron-deficiency AnemiaStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beingmate Baby & Child Food Co Ltd .
- Sponsor type
- University, hospital or other
- Collaborators
- Sir Run Run Shaw Hospital
- Responsible party
- Sponsor
- Investigators
- Fengbing Liang, Ph.D, Principal investigator, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03122938
- Sponsor's protocol ID
- RD02914009A
- Status last verified
- Apr 2017
- First submitted
- 20 Aug 2016
- Last updated
- 21 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Available when oversight authorities require.
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Daily Bovine Lactoferrin Supplementation on Fetal Development and Iron Metabolism in Healthy Pregnant Women: A Randomized Double-blind Controlled Trial
- ClinicalTrials.gov ID
- NCT03122938
- Acronym / sponsor ID
- RD02914009A
- Conditions
- Iron-deficiency Anemia
- Keywords
- lactoferrin, Iron Metabolism, iron-deficiency anemia, pregnant women, fetal development
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Beingmate Baby & Child Food Co Ltd .University, hospital or other
- Collaborators
- Sir Run Run Shaw Hospital
- Study start
- Apr 2016
- Primary completion
- Apr 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 21 Apr 2017 (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.
To assess the effects of a lactoferrin supplemented formula on fetal development , iron metabolism and immunity in healthy pregnant women. One hundred and twenty healthy pregnant women (24<gestational weeks<26) are enrolled and randomly assigned to lactoferrin-supplemented formula group (active group) or normal formula group (control group, without lactoferrin supplementation). Subjects allocated in active group consume lactoferrin supplemented formula (85mg lactoferrin per 100g) 3 times a day (81g totally), while those in control group consume formula without lactoferrin supplementation (<6mg lactoferrin per 100g formula) according to the same schedule. Routine blood test including hemoglobin and serum ferritin, and food frequency questionnaire-based review and 24h*3 dietary record are performed every 4 weeks during intervention until delivery. Body weight of newborns are recorded after delivery. The differences in iron deficiency anemia morbility of pregnant women and anthropometric measurements of newborns between groups would be analyzed after completion of this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactoferrin Group | Experimental | Dietary Supplement: lactoferrin-supplemented formulalactoferrin-supplemented formula |
| Control Group | Placebo comparator | Dietary Supplement: formula without lactoferrin supplementationformula without lactoferrin supplementation |
Who may qualify
- Ages
- 20 to 34 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- healthy pregnant women with gestational weeks between 24 and 26;
- with hemoglobin concentration > 110g / L;
- without indication of abortion;
- without infectious disease or hereditary disease;
- without iron supplementation before enrollment.
Key exclusion criteria (3 listed)
- with red blood count <3.5*10^12/L，hemoglobin concentration<110g/L or serum ferritin <20 μg/L；
- diagnosed with gestational diabetes mellitus;
- enrolled in other intervention study within past 1 month.
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 |
|---|---|---|
| lactoferrin-supplemented formulaAlso: Beingmate Nursing Mommy FormulaSubjects consume lactoferrin-supplemented formula (85mg lactoferrin per 100g) 3 times a day (81g totally). | Dietary supplement | Lactoferrin Group |
| formula without lactoferrin supplementationAlso: Beingmate Nursing Mommy FormulaSubjects consume formula without lactoferrin supplementation (<6mg lactoferrin per 100g formula) 3 times a day (81g totally). | Dietary supplement | Control Group |
Primary outcome
iron-deficiency anemia morbility of pregnant women
Time frame: every 4 weeks during intervention, namely 28th gestational weeks, 32nd gestational weeks, 36th gestational weeks and the day of delivery.
4 secondary outcomes
iron metabolism of pregnant women
Time frame: every 4 weeks during intervention, namely 28th gestational weeks, 32nd gestational weeks, 36th gestational weeks and the day of delivery.
fetal growth
Time frame: the day of delivery, recorded by nurse.
fetal growth and development
Time frame: the day of delivery,recorded by nurse immediately
fetal development
Time frame: the day of delivery, measured and recorded by nurse.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2017.
- Individual participant dataSharing planned: No. Available when oversight authorities require.
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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.
Fengbing Liang, Ph.D principal investigator
Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lactoferrin-supplemented formula and formula without lactoferrin supplementation in people with Iron-deficiency Anemia, run by Beingmate Baby & Child Food Co Ltd . at 1 site in China.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 21 Apr 2017. 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 China. 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?
Results are not available in the source record.
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?
iron-deficiency anemia morbility of pregnant women (time frame: every 4 weeks during intervention, namely 28th gestational weeks, 32nd gestational weeks, 36th gestational weeks and the day of delivery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Apr 2017.