Lactoferrin Versus Total Dose Infusion (TDI) For Treating Iron Deficiency Anemia in Pregnancy: Role of Nursing

NCT03279536 | Completed Phase 1

• 1 other identifier: WHH
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

This study consisted of 60 cases. All the cases of pregnant women are 4 months to 8 months of pregnancy. The cases divided into 30 pregnant women's were given iron supplementation without health education and another 30 were given iron supplementation and health education for comparison between them. Comparative between hemoglobin levels before and after medication. Treatment of iron deficiency anemia with iron supplementation received for one month.

Conditions

Iron Deficiency Anemia

Outcome Measures

Primary Outcomes (1)

• the change in Hb concentration

  measure the change in Hb concentration from baseline to week 4 after oral Lactoferrin treatment and relieve of symptoms of anemia

  4- 8 weeks

Secondary Outcomes (1)

• measure the change in serum iron, serum ferritin

  4-8 weeks

Study Arms (2)

Oral Lactoferrin

EXPERIMENTAL

Group A is 120 mg of Oral lactoferrin for 4 weeks Intervention: The participants 66 will receive oral Lactoferrin 120mg for 4 weeks

Combination Product: Oral lactoferrin

Total dose infusion (TDI) iron dextran

ACTIVE COMPARATOR

Group B is a parenteral total dose infusion (TDI) of LMW iron dextran 20mg/kg body weight for 4 weeks Intervention: The participants 33 will receive parental iron 20mg/kg body weight for 4 weeks

Combination Product: TDI of LMW iron dextran

Interventions

Oral lactoferrin COMBINATION_PRODUCT

Oral lactoferrin 120 mg twice /day and it's based on fast dissolving through direct swallowing per oral route with fruits flavor taste.

Also known as: Oral Fizzing Lactoferrin

Oral Lactoferrin

TDI of LMW iron dextran COMBINATION_PRODUCT

Total Dose Infusion of LMW iron dextran up to 20mg/kg body weight is infused intravenously

Also known as: Parental dextran

Total dose infusion (TDI) iron dextran

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Pregnant female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant Women aged \>18 years
• Hemoglobin\<10g/dl
• Gestational age between 14-28 weeks
• Singleton pregnancy
• Willingness to participate and signing the informed consent form

You may not qualify if:

• Anemia predominantly caused by factors other than IDA (e.g. anemia with untreated B12 or foliate deficiency, hemolytic anemia),
• Iron overload or disturbances in utilization of iron (e.g. hemochromatosis and haemosidrosis).
• Decompensated liver cirrhosis and active hepatitis (ALAT\>3 times upper limit of normal).
• Active acute or chronic infections (assessed by clinical judgment supplied with white Blood Cells (WBC) and C - reactive protein (CRP).
• Rheumatoid arthritis with symptoms or signs of active inflammation.
• Multiple allergies.
• Known hypersensitivity to parental iron or any recipients in the investigational drug products.
• Erythropoietin treatment within 8 weeks prior to the screening visit.
• Other iron treatment within 8 weeks prior to the screening visit.
• Planned elective surgery during the study.
• Participation in any other clinical within 3 months prior to the screening.
• Any other medical condition e.g. malignancy, uncontrolled hypertension, unstable ischemic heart disease, or uncontrolled diabetes mellitus.

Sponsors & Collaborators

• Woman's Health University Hospital, Egypt: lead

Study Sites (1)

Women Health Hospital

Asyut, 71111, Egypt

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

Lactoferrin

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Glycoproteins; Glycoconjugates; Carbohydrates; Transferrins; Iron-Binding Proteins; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Lactoglobulins; Whey Proteins; Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Globulins; Metalloproteins

Study Officials

• Warda Helmy, BSN

  WHH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD of Obstetric & Gynecologic Nursing

Model Details: Group A will receive oral lactoferrin \& group B will receive Total dose infusion

Study Record Dates

• First Submitted: August 30, 2017
• First Posted: September 12, 2017
• Study Start: November 1, 2017
• Primary Completion: December 30, 2018
• Study Completion: December 30, 2018
• Last Updated: October 27, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 3-6 months
• Access Criteria: Introduction, Methodology, data analysis, Findings, Discussion \& Conclusion

Locations

EG (1)