Oral Lactoferrin Versus Iron Supplementation During Pregn... | NCT03542825

Studies
Oral Lactoferrin Versus Iron Supplementation During Pregnancy

NCT03542825

Sponsor

South Valley University

Status

Completed

Last Update Posted

Dec 28, 2018Actual

Enrollment

300Actual

Phase

Phase 4

Conditions

Iron-deficiency

Interventions

Lactoferrin
Iron Supplement
Chelates, Iron

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Actual

Primary Completion Date

Sep 1, 2018Actual

Completion Date

Oct 1, 2018Actual

First Submitted Date

May 20, 2018

First Submission Date that Met QC Criteria

May 20, 2018

First Posted Date

May 31, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 27, 2018

Last Update Posted Date

Dec 28, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mohammad Abdel-Rahman Mohammad Ahmed, Principal investigator, South Valley UniversityPrincipal Investigator

Lead Sponsor

South Valley UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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].

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Lactoferrin	Drug	parallel use of the three drugs to compare the efficacy of each arm in prevention of anemia	Lactoferrin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change in haemoglobin level after 4 weeks of use.	difference in haemoglobin levelbetween before and after supplementation	4 weeks

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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).

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Pregnant women

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
South Valley University, Qena Faculty of Medicine, Obstetrics and Gynecology Department		Qina	Qena Governorate		Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
14684407	Background	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.
22512001	Background

ID	Term
D000747	Anemia, Hypochromic
D000740	Anemia
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

ID	Term
D007781	Lactoferrin
D007505	Iron-Dextran Complex
D007502	Iron Chelating Agents

ID	Term
D012697	Serine Endopeptidases
D010450	Endopeptidases
D010447	Peptide Hydrolases
D006867	Hydrolases