Oral Lactoferrin Versus Iron Supplementation During Pregnancy

NCT03542825 | Completed Phase 4 DMC

• 1 other identifier: OBGYN 003
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Iron deficiency anemia (IDA) is the condition in which there is anemia due to a lack of iron. The oral route is preferred to the parenteral route to replace iron stores \[Sharma JB; et al., 2004\]. Inorganic iron has poor bio-availability in addition to many side effects, including gastrointestinal discomfort, nausea, vomiting, diarrhea and constipation and it may sometimes increase susceptibility to infection \[ So¨lvell L; et al., 1970\].

Conditions

Iron-deficiency

Keywords

Iron; Deficiency

Outcome Measures

Primary Outcomes (1)

• change in haemoglobin level after 4 weeks of use.

  difference in haemoglobin levelbetween before and after supplementation

  4 weeks

Secondary Outcomes (1)

• side effect profile

  4 weeks

Study Arms (3)

Iron Sulphate

ACTIVE COMPARATOR

ferrous sulphate 150 mg iron capsule once daily for 3 consecutive months.

Drug: Iron Supplement

Amino acid Chelated

ACTIVE COMPARATOR

amino acid chelated iron capsule 15mg for 3 consecutive months.

Drug: Chelates, Iron

Lactoferrin

ACTIVE COMPARATOR

lactoferrin 100 mg sachets once daily for 3 consecutive months.

Drug: Lactoferrin

Interventions

Lactoferrin DRUG

parallel use of the three drugs to compare the efficacy of each arm in prevention of anemia

Lactoferrin

Iron Supplement DRUG

Iron Sulphate 150 mg once daily

Also known as: Iron Sulphate

Iron Sulphate

Chelates, Iron DRUG

Amino acid chelated iron capsules contain 15 mg

Also known as: Amino acid chelated iron

Amino acid Chelated

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women (aged 20-40 yrs.) with single fetus, in the second trimester, with normal haemoglobin level (Hb level ≥10.5 gm /dl) will be enrolled.

You may not qualify if:

• Women with anaemia (Hb level ≤10.5 gm. /dl) due to any causes, such as chronic blood loss, haemolytic anaemia and thalassemia (including thalassemia trait).
• History of peptic ulcer.
• Medical complications with pregnancy (such as cardiovascular, thyroid, pituitary, nutritional, renal, liver diseases, diabetes mellitus (DM) and hypertension (HTN).
• Fetal abnormalities such as microcephaly, intrauterine growth restriction (IUGR).

Sponsors & Collaborators

• South Valley University: lead

Study Sites (1)

South Valley University, Qena Faculty of Medicine, Obstetrics and Gynecology Department

Qina, Qena Governorate, Egypt

Location

Related Publications (4)

• Sharma JB, Jain S, Mallika V, Singh T, Kumar A, Arora R, Murthy NS. A prospective, partially randomized study of pregnancy outcomes and hematologic responses to oral and intramuscular iron treatment in moderately anemic pregnant women. Am J Clin Nutr. 2004 Jan;79(1):116-22. doi: 10.1093/ajcn/79.1.116.

  PMID: 14684407 BACKGROUND

• Pavord S, Myers B, Robinson S, Allard S, Strong J, Oppenheimer C; British Committee for Standards in Haematology. UK guidelines on the management of iron deficiency in pregnancy. Br J Haematol. 2012 Mar;156(5):588-600. doi: 10.1111/j.1365-2141.2011.09012.x.

  PMID: 22512001 BACKGROUND

• Baker EN, Baker HM. Molecular structure, binding properties and dynamics of lactoferrin. Cell Mol Life Sci. 2005 Nov;62(22):2531-9. doi: 10.1007/s00018-005-5368-9.

  PMID: 16261257 BACKGROUND

• Abu Hashim H, Foda O, Ghayaty E. Lactoferrin or ferrous salts for iron deficiency anemia in pregnancy: A meta-analysis of randomized trials. Eur J Obstet Gynecol Reprod Biol. 2017 Dec;219:45-52. doi: 10.1016/j.ejogrb.2017.10.003. Epub 2017 Oct 4.

  PMID: 29059584 BACKGROUND

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

Lactoferrin; Iron-Dextran Complex; Iron Chelating Agents

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; Coordination Complexes; Organic Chemicals; Dextrans; Glucans; Polysaccharides; Chelating Agents; Sequestering Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Mohammad AM Ahmed, MD

  South Valley University, Qena Faculty of Medicine, Obstetrics and Gynecology Department, Qena, Qena, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Double blinded (participant and care giver)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 3 groups of pregnant women will be assigned for each intervention

Study Record Dates

• First Submitted: May 20, 2018
• First Posted: May 31, 2018
• Study Start: January 1, 2018
• Primary Completion: September 1, 2018
• Study Completion: October 1, 2018
• Last Updated: December 28, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: throughout the period of research until end of the study
• Access Criteria: IPD will be shared with the predetermined group of researchers as accepted by the local ethical and research committee.

Locations

EG (1)