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CompletedNCT03456258LactoferrinUpdated Mar 7, 2018

Lactoferrin Versus Ferrous Sulphate for the Treatment of Iron Deficiency Anemia During Pregnancy

An interventional study of Complete blood count in Iron Deficiency Anemia of Pregnancy, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to female participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-07.

Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
Female
01

Study summary

The study aims to compare the efficacy and the safety of Lactoferrin versus ferrous sulphate for the treatment of iron deficiency anemia during pregnancy.

Read the detailed description

The study was done at ainshams university maternity hospital on 100 pregnant women randomized in two groups .

Group one lactoferrin group Group two ferrous sulphate group

02

Conditions studied

03

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • pregnant women from 20 to 40 years
  • iron deficiency anemia (mild and moderate)
  • gestational age 13 to 26 weeks
  • singleton viable pregnancy.

Exclusion criteria

Exclusion Criteria:

  • history of anemia due to chronic blood loss
  • hemolytic anemia
  • severe anemia
  • history of peptic ulcer
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Lactoferrin

    To measure hemoglobin difference and serum ferritin

    Diagnostic Test: Complete blood count

  • Experimental
    Ferrous sulphate

    To measure hemoglobin difference and serum ferritin

    Diagnostic Test: Complete blood count

Interventions

  • Diagnostic testComplete blood count

    To measure hemoglobin difference and serum ferritin levels .

    Also known as: Serum ferritin

05

What researchers measure

Primary outcomes

  1. hemoglobin level

    Measure hemoglobin level two months after treatment

    Time frame: 2 months

Secondary outcomes

  1. Serum ferritin

    Measure serum ferritin level

    Time frame: 2 months

06

Study locations

1 site
  • Ainshams maternity hospital
    Cairo, Abbasia 11591, Egypt
07

Registry details

Key details

Study ID
NCT03456258
Lead sponsor
Ain Shams University
Responsible party
Ahmed Ragab (Principal investigator, Ain Shams University) — Principal investigator
First posted
Mar 7, 2018
Start date
Sep 5, 2017
Primary completion
Dec 10, 2017
Completion
Jan 15, 2018
Last update
Mar 7, 2018

Study contacts

Ahmed M Ragab, MBBCH
principal investigator · Ainshams university maternity hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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