Effectiveness of adaptation of the dose of iron supplementation in pregnancy on maternal-child health. Randomized clinical trial (ECLIPSES)

Phase 1

• Conditions: Pregnant women, less than 12 week of gestations,without anemia (Hb <110 d / dL) in the pre-analytical at 12 weeks; Therapeutic area: Diseases [C] - Parasitic Diseases [C03]

• Registration Number: EUCTR2012-005480-28-ES
• Lead Sponsor: Institut d?Investigació en Atenció Primaria IDIAP Jordi Gol

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-09
• Last Update Posted: 3 July 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

? adult woman
? ICS belonging to
? pregnant less than 12 weeks gestation
? to understand the Castilian or Catalan
? sign the informed consent
? without anemia (Hb <110 d / dL) in the pre-analytical at 12 weeks
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 878
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified