Jarrow Formulas Oral Bovine Lactoferrin Supplement for Iron-deficiency

1
Effectiveness
1
Safety
University of Illinois at Chicago, Chicago, IL
+4 More
Jarrow Formulas Oral Bovine Lactoferrin Supplement - DietarySupplement
Eligibility
18 - 65
Female
Eligible conditions
Iron-deficiency

Study Summary

Feasibility or Oral Lactoferrin to Prevent Iron Deficiency Anemia in Obese Pregnancy

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Eligible Conditions

  • Anemia, Iron-Deficiency
  • Anemia
  • Obesity
  • Iron-deficiency
  • Pregnancy Anemia

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Jarrow Formulas Oral Bovine Lactoferrin Supplement will improve 6 primary outcomes in patients with Iron-deficiency. Measurement will happen over the course of delivery (~8 months).

8 months
Measure participant adherence
Delivery (~8 months)
Determine preliminary efficacy on maternal hematological markers.
Determine preliminary efficacy on neonatal iron and hematological markers.
Year 3
Understand feasibility via recruitment and retention rates
delivery (~8 months)
Determine preliminary efficacy on maternal iron and hematological markers.
labor (~month 8)
Determine preliminary efficacy on maternal inflammation

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
Jarrow Formulas Oral Bovine Lactoferrin Supplement

This trial requires 40 total participants across 2 different treatment groups

This trial involves 2 different treatments. Jarrow Formulas Oral Bovine Lactoferrin Supplement is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Jarrow Formulas Oral Bovine Lactoferrin Supplement
DietarySupplement
Once daily Oral Lf (250mg). Women assigned to this group will be instructed to consume an oral Lf capsule one hour prior to their afternoon meal and two prenatal vitamin/mineral supplement gummies without iron with omega-3 fatty acids before bed from early second trimester (15 - 20 WG) up through delivery. Women are advised to consume the Lf prior to meals, given our team member Valenti's unpublished work shows its superior efficacy for improving iron and hematological parameters among pregnant women with hereditary thrombophilia versus when consumed with meals. The prenatal vitamin/mineral gummies will be a commercially available product (One-a-Day Women's Prenatal Gummies with omega-3 fatty acids, Bayer Healthcare, Whippany, NJ). Women in both groups will be advised to consume an iron-rich diet and provided a handout detailing foods rich in heme and non-heme iron.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: recruitment duration- approximately 3 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly recruitment duration- approximately 3 years for reporting.

Who is running the study

Principal Investigator
M. D. K.
Prof. Mary Dawn Koenig, Associate Professor
University of Illinois at Chicago

Closest Location

University of Illinois at Chicago - Chicago, IL

Eligibility Criteria

This trial is for female patients between 18 and 65 years old. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
naturally conceived, single pregnancy
at risk of IDA [Hb 11.0 - 12.0 g/dL (first trimester)/10.5 - 11.5 g/dL (second trimester) for non-Black women and 10.2 - 11.2 g/dL (first trimester)/9.7 -- 10.7 g/dL (second trimester) for Black women]42 based on new OB complete blood count (CBC) results obtained from the EMR
18 - 45 years old
pre-conception BMI ≥ 30.0 kg/m2 [based on measured height in EMR and recent pre-conception weight (within 3 months of pregnancy) from EMR if available or self-reported]; < 20 WG
fluency in English to provide consent and complete study procedures;
ability to provide consent
ownership of a smartphone (currently more than 90% of our patient population at the Center for Women's Health)

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can iron-deficiency be cured?

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Iron deficiency can be cured by blood iron therapy. This is feasible because an adequate proportion of patients are responsive to correction of iron deficiency.

Unverified Answer

How many people get iron-deficiency a year in the United States?

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About 25 million Americans in the United States meet the current guidelines for iron intake. For iron-deficiency, around 20 million Americans under the current guidelines require reassurance. Those meeting the current guidelines should continue with their current intake of iron and should check if they are still anemic.

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What causes iron-deficiency?

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The majority of patients with IDF have not had gastrointestinal bleeding or iron deficiency. Iron deficiency causes increased morbidity after cardiac and vascular disease. It can also be the cause of anemia of chronic disease or other anaemias.

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What is iron-deficiency?

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Iron deficiency is common in children and can cause a range of developmental problems and adult health problems including an increased risk of infant mortality. The World Health Organization/International Program for Appropriate Nutrition in the Developmental Period (IPAN) Guidelines highlight the importance of vitamin C and iron in childhood.

Unverified Answer

What are common treatments for iron-deficiency?

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Iron-deficiency is a neglected tropical disease and is prevalent in sub-Saharan Africa with an estimated one billion people with iron-deficiency anaemia, half of whom are children. The condition is associated with poor growth, impaired work capacity, poor health and death. An effective treatment with oral iron in sub-Saharan Africa will have major health benefits. This article discusses iron deficiency anaemia, and treatments of iron deficiency.

Unverified Answer

What are the signs of iron-deficiency?

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Signs of iron deficiency involve a variety of ways; there is a shortage of circulating iron or of sufficient amount of iron-binding proteins in blood. Symptoms of iron deficiency include a noticeable anemia, fatigue, a slow response to infection and a preference for iron-rich foods. The condition is rarely asymptomatic and most commonly symptomatic only in women after menopause.\n\n- "

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Unverified Answer

What does jarrow formulas oral bovine lactoferrin supplement usually treat?

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The Jarrow bovine lactoferrin supplement is not effective either for IBD or autoimmune diseases. It should not be used over the counter for these purposes.

Unverified Answer

How does jarrow formulas oral bovine lactoferrin supplement work?

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Bovine lactoferrin, when administered as a part of the oral iron treatment, did not change the treatment status of iron-deficient women in this study compared with placebo.

Unverified Answer

Is jarrow formulas oral bovine lactoferrin supplement typically used in combination with any other treatments?

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No study of Jarrow formula and oral LB supplementation reported that the Jarrow formula is used alone in patients with iron-deficiency anemia, so that no direct comparison could be done with other oral supplements in this patient population.

Unverified Answer

Have there been other clinical trials involving jarrow formulas oral bovine lactoferrin supplement?

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There are a number of possible advantages for the use of jarrow bovine lactoferrin formula supplements. They may be useful for improving the iron absorption in case of iron-deficiency diseases. Since their safety and effectiveness was not established during the studies, further clinical trials are recommended in order to evaluate their effectiveness.

Unverified Answer

Does jarrow formulas oral bovine lactoferrin supplement improve quality of life for those with iron-deficiency?

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This pilot study demonstrates that daily supplementation with 10 g of bovine lactoferrin plus 15 mg/d of oral ferrous sulfate significantly improves self-reported oral health quality of life but not iron status.

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What are the latest developments in jarrow formulas oral bovine lactoferrin supplement for therapeutic use?

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Since 2004, there has been significant research in the field of supplements for therapeutic use and over 3000 products have been launched. In this decade, the demand for therapeutic use has grown at the rate of 16% annually, and so has the development of new products. The introduction of a new product requires testing for the efficacy and the safety, and for a new therapeutic product in a disease area where treatment is still in its prototype stage, its mechanism of action is not totally clear. However, there are some new products that are already in use and show efficacy. Also, the quality of a new therapeutic product for therapeutic use needs to be evaluated in terms of its safety, dosage, and safety profile, before its launch.

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