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Effectiveness of Adaptation of the Dose of Iron Supplementation in Pregnancy on Maternal-child Health. (ECLIPSES) ((ECLIPSES))

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03196882
Recruitment Status : Completed
First Posted : June 23, 2017
Last Update Posted : June 23, 2017
Sponsor:
Collaborators:
University Rovira i Virgili
Catalan Institute of Health
Hospital Universitari Joan XXIII de Tarragona.
Carlos III Health Institute
Information provided by (Responsible Party):
Victoria Arija Val, Jordi Gol i Gurina Foundation

Brief Summary:

Currently, there is no consensus regarding iron supplementation dose that is most beneficial for maternal and offspring health during gestation. This deficit, or excess, of iron prejudices the mother-child wellbeing. Therefore the hypotheses are that an iron supplementation adapted to values of hemoglobin at the start of the pregnancy will would be more effective in preventing iron deficiency, without increasing the risk of hemoconcentration by the end of pregnancy. This would be helped optimize mother-child health status.

The aims of the study are to determine the highest level of effectiveness of iron supplementation adapted to hemoglobin (Hb) levels in early pregnancy, which would be optimum for mother-child health.

To accomplish this objective a Randomized Clinical Trial (RCT) triple-blinded was designed. The study is structured as a RCT with 2 strata, depending on the Hb levels before week 12 of gestation.

Stratum 1: If Hb from 110 to 130 g/L, randomly assigned at week 12 to receive iron supplement of 40 or 80 mg/d.

Stratum 2: If Hb >130 g/L, randomly assigned at week 12 to receive iron supplement of 40 or 20 mg/d.

This study will be conducted in non-anemic pregnant women at early gestation stage, and their subsequent newborns. The data recollected to mothers will be: socio-economic data, clinical history, food item frequency, lifestyle and emotional state, and adherence to iron supplement prescription. In addition, biochemical measured will be Hemoglobin, serum ferritin, C reactive protein, cortisol, and alterations in the HFE gene (C282Y, H63D). In children, the data collected will be: ultrasound fetal biometry, anthropometric measurements, and temperament development

Should conclusive outcomes be reached, the study would indicate the optimal iron supplementation dose required to promote maternal and infant health. These results would contribute towards developing guidelines for good clinical practice.


Condition or disease Intervention/treatment Phase
Anemia Ferropenic Risk of Hemoconcentration (Iron Levels >130g/L) Drug: 40mg/day of iron Drug: 20mg/day of iron Drug: 80mg/day of iron Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 704 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Multi-centered, parallel groups, controlled, triple blind, randomized clinical trial (RCT) subdivided in 2 strata as a function of the hemoglobin (Hb) levels at the start of the pregnancy:

Stratum 1: If Hb from 110 to 130 g/L, randomly assigned at week 12 to receive iron supplement of 40 or 80 mg/d.

Stratum 2: If Hb >130 g/L, randomly assigned at week 12 to receive iron supplement of 40 or 20 mg/d.

The study is structured as a RCT with 2 stratum, depending on the Hb levels before week 12 of gestation. In each stratum there are two arms of intervention. Total 4 arms.

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The study will be triple blind: the participant, the health-care professional, and the investigator-statistician. The treatment drug will be administered "blind" i.e. the doses are not identifiable since the packaging has the same format, presentation, and visual characteristics. For Stratum 1, the treatments will be designated as A or B, and for Stratum 2 they will be designated as C or D. The laboratory of MEIJI TEDEC FARMA, SA will be responsible for manufacturing, packaging and labeling the study medications. Only MEIJI TEDEC FARMA, SA and the Clinical Pharmacology Service of the Vall d'Hebron Hospital in Barcelona will know the distribution codes and the composition of each of the treatments.
Primary Purpose: Prevention
Official Title: Effectiveness of Adaptation of the Dose of Iron Supplementation in Pregnancy on Maternal-child Health. Randomized Clinical Trial (ECLIPSES)
Actual Study Start Date : July 10, 2013
Actual Primary Completion Date : January 30, 2017
Actual Study Completion Date : January 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Stratum 1: 40 mg/day of iron

Ferrimanitol ovoalbumin. 40mg of iron in a sachet (powder for oral solution) by mouth, every 24 hours from 12th week of gestation to partum

Stratum 1: If the levels of Hb are situated between 110 and 130 g/L, the individual will be randomly assigned to an iron dose supplement of 40 (medium supplementation) or 80 mg/d (high supplementation)

Drug: 40mg/day of iron
Ferrimanitol ovalbumin granulated. Powder for oral solution. The doses of 40 mg per day of elemental iron correspond to 300 mg ferrimanitol ovoalbumin
Other Name: PROFER 40 mg

Experimental: Stratum 1: 80 mg/day of iron

Ferrimanitol ovoalbumin. 80mg of iron in a sachet (powder for oral solution) by mouth, every 24 hours from 12th week of gestation to partum

Stratum 1: If the levels of Hb are situated between 110 and 130 g/L, the individual will be randomly assigned to an iron dose supplement of 40 (medium supplementation) or 80 mg/d (high supplementation)

Drug: 80mg/day of iron
Ferrimanitol ovalbumin granulated. Powder for oral solution The doses of 80 mg per day of elemental iron correspond to 600 mg ferrimanitol ovoalbumin.
Other Name: PROFER 80 mg

Active Comparator: stratum 2: 40 mg/day of iron

Ferrimanitol ovoalbumin. 40mg of iron in a sachet (powder for oral solution) by mouth, every 24 hours from 12th week of gestation to partum

Stratum 2: If the levels of Hb are >130 g/L, the individual will be randomly assigned to an iron dose supplement of 40 (medium supplementation) or 20 mg/d (low supplementation)

Drug: 40mg/day of iron
Ferrimanitol ovalbumin granulated. Powder for oral solution. The doses of 40 mg per day of elemental iron correspond to 300 mg ferrimanitol ovoalbumin
Other Name: PROFER 40 mg

Experimental: stratum 2: 20 mg/day of iron

Ferrimanitol ovoalbumin. 20mg of iron in a sachet (oral solution) by mouth, every 24 hours from 12th week of gestation to partum

Stratum 2: If the levels of Hb are >130 g/L, the individual will be randomly assigned to an iron dose supplement of 40 (medium supplementation) or 20 mg/d (low supplementation)

Drug: 20mg/day of iron
Ferrimanitol ovalbumin granulated Powder for oral solution. The doses of 20 mg per day of elemental iron correspond to 150 mg ferrimanitol ovoalbumin
Other Name: FERROPROTINA




Primary Outcome Measures :
  1. Anemia [ Time Frame: at week 36 of gestation (3rd visit of study) ]
    - Anemia is defined as Hb <110 g/L in the 1st and 3rd trimester, Hb <110 in 2nd trimester (Centers for Disease Control and Prevention, 1998).

  2. ferropenic anemia [ Time Frame: at week 36 of gestation (3rd visit of study) ]
    - Ferropenic anemia is defined as: Hb < the normal limit, and serum ferritin (SF) <15 μg/L (WHO, 2007)

  3. Risk of hemoconcentration [ Time Frame: at week 36 of gestation (3rd visit of study) ]
    - Hemoconcentration risk is defined as: Hb >130 g/L in the 2nd and /or3rd trimester (Peña-Rosas y Viteri, 2009).


Secondary Outcome Measures :
  1. C282Y polymorphisms of HFE gene [ Time Frame: Blood analysis at 12 weeks of gestation. ]
    Presence or absence of polymorphisms: C282Y and H63D

  2. Anthropometric parameters of newborn. [ Time Frame: At birth ]
    weight (g)

  3. Neurorconductual development of newborn (Bayley Scales) [ Time Frame: 40days post-partum ]
    Units on a scale (score).

  4. H63D polymorphisms of HFE gene [ Time Frame: Blood analysis at 12 weeks of gestation. ]
    Presence or absence of polymorphisms: C282Y and H63D



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult woman
  • ICS belonging to
  • Pregnant less than 12 weeks gestation,
  • To understand the Spanish or Catalan
  • Sign the informed consent
  • Without anemia (Hb <110 d / dL) in the pre-analytical at 12 weeks

Exclusion Criteria:

  • Multiple or risk pregnancy.
  • Taking iron supplements containing 10mg iron than in the previous three months
  • Pregnant women with hypersensitivity to the active substance, hypersensitivity to egg proteins or intolerant to fructose or galactose.
  • chronic or severe pre-existing disease that affects the nutritional development, such as cancer, diabetes mellitus and other metabolic diseases, malabsorptive diseases such as Crohn's disease, ulcerative colitis, gastro-duodenal ulcers, and liver diseases such as chronic hepatitis, liver cirrhosis and chronic pancreatitis.
  • Immunosuppression: chronic HIV infection, transplant, neutropenic, or patients receiving immunosuppressive therapy.

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): NCT03196882


Locations
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Spain
Atención a la Salud Sexual y Reproductiva (ASSIR)- REUS- Altebrat
Reus, Tarragona, Spain
Atención a la Salud Sexual y Reproductiva (ASSIR)- Tarragona Valls
Tarragona, Spain
Sponsors and Collaborators
Victoria Arija Val
University Rovira i Virgili
Catalan Institute of Health
Hospital Universitari Joan XXIII de Tarragona.
Carlos III Health Institute
Investigators
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Study Director: Victoria Arija, MD Professor Institut d'Investigació en Atenció Primària, IDIAP Jordi Gol i Gurina, Catalonia, Spain - Nutrition and Public Health Unit, Rovira i Virgili University

Additional Information:
Publications:
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Responsible Party: Victoria Arija Val, Professor, MD, Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier: NCT03196882    
Other Study ID Numbers: IJG-FER-2012
2012-005480-28 ( EudraCT Number )
PI12/02777 ( Other Grant/Funding Number: Instituto de Salud Carlos III,Ministerio de Sanidad )
First Posted: June 23, 2017    Key Record Dates
Last Update Posted: June 23, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Victoria Arija Val, Jordi Gol i Gurina Foundation:
pregnancy
iron
hemoglobin
supplementation
neurodevelopment
newborn
anemia
clinical trial
Additional relevant MeSH terms:
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Anemia
Anemia, Iron-Deficiency
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Iron
Pharmaceutical Solutions
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs