Feasibility of oral lactoferrin to prevent iron deficiency anemia in obese pregnancy
口服乳铁蛋白预防肥胖妊娠缺铁性贫血的可行性
基本信息
- 批准号:10558588
- 负责人:
- 金额:$ 23.99万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2021
- 资助国家:美国
- 起止时间:2021-02-20 至 2025-01-31
- 项目状态:未结题
- 来源:
- 关键词:AdherenceAffectAgeApplications GrantsAttenuatedBiological AvailabilityBiological MarkersBody mass indexCattleChronicCirculationClinical TrialsComplexDataDietDietary IronEndowmentEnrollmentEquilibriumErythropoiesisFerrous SulfateFetusFutureGeneticGlycoproteinsGrantHematological DiseaseHematologyHepatocyteHigh PrevalenceHomeostasisHormonesInflammationInflammatoryIntakeInterventionIntervention TrialIronIron deficiency anemiaLactoferrinLiverMacrophageMammalsMaternal HealthMediatingMethodsMilkMonitorNational Heart, Lung, and Blood InstituteNatural CompoundNeonatalNon obeseObesityOralOral AdministrationPatientsPersonsPregnancyPregnancy ComplicationsPregnant WomenPrenatal carePreventionProceduresProductionProviderRandomizedRandomized, Controlled TrialsRegulationResearch InfrastructureRiskRisk FactorsRoleSecond Pregnancy TrimesterSmall IntestinesSodium ChlorideSupplementationSystemTestingTimeUnited StatesWomanabsorptionadherence rateadverse pregnancy outcomeclinical infrastructuredata infrastructuredesignefficacy trialexperiencefeasibility trialfetalhepcidinimprovedin uteroiron deficiencyiron supplementiron supplementationmembermetal transporting protein 1neonatal healthneonateneurodevelopmentnovelobesity in pregnancyoral supplementationoverexpressionpilot testpregnantprenatalprepregnancy obesitypreventprophylacticprospectiverandomized trialrecruitreproductiveretention ratestandard of caresystemic inflammatory responsetreatment as usualtrial planning
项目摘要
ABSTRACT
Maternal iron deficiency anemia (IDA) increases the risk of adverse pregnancy outcomes and can negatively
impact the iron endowment of the neonate that may cause irreversible deleterious effects on neurodevelopment.
To avert IDA in pregnancy, women are universally prescribed a daily oral supplement containing ~27 mg of iron.
However, there is growing concern regarding the efficacy of this one-size-fits-all approach for women with
systemic inflammation, including women with obesity. Obese women experience disruption to the hepcidin-
ferroportin complex deeming iron from diet, including supplemental iron, and body stores less bioavailable. This
indicates an urgent need to develop and test new methods to prevent maternal IDA among women with obesity.
In this planning grant application, we will develop the clinical and research infrastructure to test the preliminary
efficacy of oral bovine lactoferrin (bLf) supplementation for the prevention of maternal IDA among obese women.
Lactoferrin is a natural compound found in secretions from mammals, including milk, and is an important
regulator of body iron balance given its effects on inflammation and the hepcidin-ferroportin complex. Daily oral
bLf has been shown to be superior to oral iron supplementation for treating IDA in pregnant women with
inflammation but has not been studied for its ability to prevent IDA in pregnancy. The specific aims of this clinical
trial planning grant include: 1) Establish the clinical and research infrastructure to recruit, enroll, and randomize
obese women at risk of IDA to an oral bLf intervention in pregnancy. In this aim we will establish, test, refine and
finalize the clinical and research infrastructure and implementation procedures, including a provider referral
system, real-time adherence monitoring, and data infrastructure; and 2) Pilot test a randomized controlled trial
of oral bLf supplementation from early second trimester up through delivery among 40 pregnant women with
obesity at risk of IDA. In this aim we seek to understand recruitment, adherence, and retention rates and
intervention acceptability to determine feasibility and preliminary efficacy on maternal inflammation and maternal
and neonatal iron and hematological-related markers. This study will provide first of its kind data, necessary and
sufficient to inform and develop a large-scale efficacy trial of oral bLf as a safe and scalable natural compound
for the prevention of IDA among obese women. Ultimately if successful, this project is an important first step
toward improving prenatal care for obese women who represent more than a third of reproductive-age women
in the United States.
摘要
母亲缺铁性贫血(IDA)增加不良妊娠结局的风险,
影响新生儿的铁营养,可能对神经发育造成不可逆的有害影响。
为了避免怀孕期间的IDA,女性普遍每天口服含有约27毫克铁的补充剂。
然而,越来越多的人担心这种一刀切的方法对患有糖尿病的妇女的有效性。
全身性炎症,包括肥胖妇女。肥胖女性的铁调素会受到干扰-
膜铁转运蛋白复合物认为铁来自饮食,包括补充铁,并且身体储存较少的生物可利用性。这
表明迫切需要开发和测试新的方法来预防肥胖妇女中的孕产妇IDA。
在这项规划拨款申请中,我们将开发临床和研究基础设施,以测试初步的
口服牛乳铁蛋白(bLf)补充剂预防肥胖妇女母体IDA的有效性。
乳铁蛋白是在哺乳动物的分泌物(包括乳汁)中发现的天然化合物,并且是重要的免疫调节剂。
由于其对炎症和铁调素-膜铁转运蛋白复合物的作用,其是身体铁平衡的调节剂。每日口服
已证明bLf在治疗患有IDA的孕妇中上级口服铁补充剂。
但尚未研究其预防妊娠期IDA的能力。本临床的具体目标
试验计划拨款包括:1)建立临床和研究基础设施,以招募、登记和随机化
有IDA风险的肥胖妇女在怀孕期间接受口服bLf干预。为此,我们将建立、测试、完善和
完成临床和研究基础设施和实施程序,包括提供者转介
系统、实时依从性监测和数据基础设施; 2)随机对照试验的初步测试
在40名孕妇中,
肥胖有患缺铁性贫血的风险。在这一目标中,我们试图了解招聘,坚持和保留率,
干预的可接受性,以确定对母体炎症和母体
以及新生儿铁和血液学相关标志物。这项研究将首次提供必要的数据,
足以告知和开发口服bLf作为安全和可扩展的天然化合物的大规模疗效试验
预防肥胖妇女的缺铁性贫血。最终如果成功,这个项目是重要的第一步
旨在改善占育龄妇女三分之一以上的肥胖妇女的产前护理
在美国
项目成果
期刊论文数量(1)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
Recruitment and Retention of Urban Pregnant Women to a Clinical Study Administering an Oral Isotope Dietary Tracer.
- DOI:10.1089/whr.2022.0015
- 发表时间:2022
- 期刊:
- 影响因子:0
- 作者:Koenig MD;Tussing-Humphreys L;DeMartelly V;LaBomascus B;OjiNjideka Hemphill N;Welke L;Pezley L;Ruchob R;Hirsch B;Furlette-Koski M;Kessee N;Ferrans CE
- 通讯作者:Ferrans CE
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
数据更新时间:{{ journalArticles.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ monograph.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ sciAawards.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ conferencePapers.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ patent.updateTime }}
Mary Dawn Koenig其他文献
Mary Dawn Koenig的其他文献
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
{{ truncateString('Mary Dawn Koenig', 18)}}的其他基金
Feasibility of oral lactoferrin to prevent iron deficiency anemia in obese pregnancy
口服乳铁蛋白预防肥胖妊娠缺铁性贫血的可行性
- 批准号:
10356064 - 财政年份:2021
- 资助金额:
$ 23.99万 - 项目类别:
相似海外基金
Hormone therapy, age of menopause, previous parity, and APOE genotype affect cognition in aging humans.
激素治疗、绝经年龄、既往产次和 APOE 基因型会影响老年人的认知。
- 批准号:
495182 - 财政年份:2023
- 资助金额:
$ 23.99万 - 项目类别:
Investigating how alternative splicing processes affect cartilage biology from development to old age
研究选择性剪接过程如何影响从发育到老年的软骨生物学
- 批准号:
2601817 - 财政年份:2021
- 资助金额:
$ 23.99万 - 项目类别:
Studentship
RAPID: Coronavirus Risk Communication: How Age and Communication Format Affect Risk Perception and Behaviors
RAPID:冠状病毒风险沟通:年龄和沟通方式如何影响风险认知和行为
- 批准号:
2029039 - 财政年份:2020
- 资助金额:
$ 23.99万 - 项目类别:
Standard Grant
Neighborhood and Parent Variables Affect Low-Income Preschool Age Child Physical Activity
社区和家长变量影响低收入学龄前儿童的身体活动
- 批准号:
9888417 - 财政年份:2019
- 资助金额:
$ 23.99万 - 项目类别:
The affect of Age related hearing loss for cognitive function
年龄相关性听力损失对认知功能的影响
- 批准号:
17K11318 - 财政年份:2017
- 资助金额:
$ 23.99万 - 项目类别:
Grant-in-Aid for Scientific Research (C)
Affect regulation and Beta Amyloid: Maturational Factors in Aging and Age-Related Pathology
影响调节和 β 淀粉样蛋白:衰老和年龄相关病理学中的成熟因素
- 批准号:
9320090 - 财政年份:2017
- 资助金额:
$ 23.99万 - 项目类别:
Affect regulation and Beta Amyloid: Maturational Factors in Aging and Age-Related Pathology
影响调节和 β 淀粉样蛋白:衰老和年龄相关病理学中的成熟因素
- 批准号:
10166936 - 财政年份:2017
- 资助金额:
$ 23.99万 - 项目类别:
Affect regulation and Beta Amyloid: Maturational Factors in Aging and Age-Related Pathology
影响调节和 β 淀粉样蛋白:衰老和年龄相关病理学中的成熟因素
- 批准号:
9761593 - 财政年份:2017
- 资助金额:
$ 23.99万 - 项目类别:
How age dependent molecular changes in T follicular helper cells affect their function
滤泡辅助 T 细胞的年龄依赖性分子变化如何影响其功能
- 批准号:
BB/M50306X/1 - 财政年份:2014
- 资助金额:
$ 23.99万 - 项目类别:
Training Grant
Inflamm-aging: What do we know about the effect of inflammation on HIV treatment and disease as we age, and how does this affect our search for a Cure?
炎症衰老:随着年龄的增长,我们对炎症对艾滋病毒治疗和疾病的影响了解多少?这对我们寻找治愈方法有何影响?
- 批准号:
288272 - 财政年份:2013
- 资助金额:
$ 23.99万 - 项目类别:
Miscellaneous Programs