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Substitution of the Normal Levels of Iron and Hemoglobin in Pregnant Women With Iron Supplement

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ClinicalTrials.gov Identifier: NCT02957643
Recruitment Status : Unknown
Verified November 2016 by ANGELOS DANIILIDIS, Hippocration General Hospital.
Recruitment status was:  Not yet recruiting
First Posted : November 8, 2016
Last Update Posted : November 8, 2016
Sponsor:
Information provided by (Responsible Party):
ANGELOS DANIILIDIS, Hippocration General Hospital

Brief Summary:
The purpose of the study is to investigate the effectiveness of iron in the treatment of iron deficiency in pregnant 2nd and 3rd quarter. Every 30 days the investigators measure the hemoglobin, hematocrit and iron in serum and assess the course of treatment.

Condition or disease Intervention/treatment Phase
Prevention of Anemia Drug: Iron Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : November 2016
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Arm Intervention/treatment
Placebo Comparator: pregnant women
iron dosage 1 per day for 3 months
Drug: Iron
Experimental: pregnant women with low hemoglobin levels
iron dosage 1 per day for 6 months
Drug: Iron



Primary Outcome Measures :
  1. Measured and reported effectiveness of iron in the treatment of iron deficiency in pregnant 2nd and 3rd quarter with questionnaire [ Time Frame: up to 24 months ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age more or equal of 18 years
  2. Registration consent
  3. Have complete 12h week of pregnancy
  4. Hemoglobin levels <10,5 ptl
  5. Hematocrit < 32 %

Exclusion Criteria:

  1. Age <18 years
  2. Absent registration consent
  3. Step of pregnancy less than 12 weeks
  4. Coadministration formulations iron oral or parenterally
  5. Background of liver kirrosis
  6. Background of aimosidirosis
  7. Background acquired or chronic aimatochromatosis
  8. Aplastic , Hemolytic anemia and chronic diseases
  9. Chronic pancreatitis
  10. Subjective renal or/and liver disease
  11. Hypothyroidism or yperthyreoeidismos

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02957643


Contacts
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Contact: ANGELOS DANIILIDIS, Ass Prof 6932211395 ext 0030 ANGEDAN@HOTMAIL.COM
Contact: GEORGIOS CHOROZOGLOU, MD, Msc 00306942853182 gchorozoglou@gmail.com

Sponsors and Collaborators
Hippocration General Hospital
Investigators
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Principal Investigator: PANAGIOTIS MATSOUKATIDIS, MD,Msc Aristotle University of Thessaloniki School of Medicine
Principal Investigator: CHARALABOS KOLVATZIS, MD Aristotle University of Thessaloniki School of Medicine

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Responsible Party: ANGELOS DANIILIDIS, Assistant professor of obstetrics and gynaecology A.U.TH., Hippocration General Hospital
ClinicalTrials.gov Identifier: NCT02957643     History of Changes
Other Study ID Numbers: HippokratioGH
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: November 8, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Iron
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs