Oral Lactoferrin Versus Iron Supplementation During Pregnancy

Sponsor

South Valley University (Other)

Overall Status

Completed

CT.gov ID

NCT03542825

Collaborator

(none)

300

Enrollment

Location

Arms

Actual Duration (Months)

33.4

Patients Per Site Per Month

Study Details

Study Description

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].

Condition or Disease	Intervention/Treatment	Phase
Iron-deficiency	Drug: Lactoferrin Drug: Iron Supplement Drug: Chelates, Iron	Phase 4

Detailed Description

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. This allows the normal mechanism of absorption to be used, in addition to being an inexpensive and effective treatment [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].

Furthermore, routine iron supplementation has recently been challenged. The British Society for Hematology, Obstetric Hematology Group (BSH OHG) and the British Committee for Standards in Hematology (BCSH) recommend screening by Full blood count (FBC) at booking and at 28 weeks instead of universal iron supplementation [Pavord S. 2012]. Lactoferrin is a high-affinity cationic iron binding glycoprotein [Baker EN, 2005]. Bovine Lactoferrin is currently available pharmaceutical preparation. It is in to safe and effective in treating pregnant women suffering from ID and IDA [Mohamed Rezk, et al. 2015]. This study will compare the efficacy of these three available options.

Study Design

Study Type:

Interventional

Actual Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

3 groups of pregnant women will be assigned for each intervention3 groups of pregnant women will be assigned for each intervention

Masking:

Double (Participant, Care Provider)

Masking Description:

Double blinded (participant and care giver)

Primary Purpose:

Prevention

Official Title:

Outcome of Oral Lactoferrin in Comparison to Amino Acid Chelated Iron and Ferrous Sulphate Supplementation During Pregnancy: A Randomized Control Trial

Actual Study Start Date :

Jan 1, 2018

Actual Primary Completion Date :

Sep 1, 2018

Actual Study Completion Date :

Oct 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Iron Sulphate ferrous sulphate 150 mg iron capsule once daily for 3 consecutive months.	Drug: Iron Supplement Iron Sulphate 150 mg once daily Other Names: Iron Sulphate
Active Comparator: Amino acid Chelated amino acid chelated iron capsule 15mg for 3 consecutive months.	Drug: Chelates, Iron Amino acid chelated iron capsules contain 15 mg Other Names: Amino acid chelated iron
Active Comparator: Lactoferrin lactoferrin 100 mg sachets once daily for 3 consecutive months.	Drug: Lactoferrin parallel use of the three drugs to compare the efficacy of each arm in prevention of anemia

Arm

Intervention/Treatment

Active Comparator: Iron Sulphate

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

Drug: Iron Supplement

Iron Sulphate 150 mg once daily

Other Names:

Iron Sulphate

Active Comparator: Amino acid Chelated

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

Drug: Chelates, Iron

Amino acid chelated iron capsules contain 15 mg

Other Names:

Amino acid chelated iron

Active Comparator: Lactoferrin

lactoferrin 100 mg sachets once daily for 3 consecutive months.

Drug: Lactoferrin

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

Outcome Measures

Primary Outcome Measures

change in haemoglobin level after 4 weeks of use. [4 weeks]
difference in haemoglobin levelbetween before and after supplementation

Secondary Outcome Measures

side effect profile [4 weeks]
All women will be asked to keep a diary of five potential gastrointestinal side effects (Epigastric pain, nausea, vomiting, diarrhoea and constipation).

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

• 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.

Exclusion Criteria:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	South Valley University, Qena Faculty of Medicine, Obstetrics and Gynecology Department	Qinā	Qena	Egypt

Sponsors and Collaborators

South Valley University

Investigators

Principal Investigator: Mohammad AM Ahmed, MD, South Valley University, Qena Faculty of Medicine, Obstetrics and Gynecology Department, Qena, Qena, Egypt