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

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.

Conditions

• Anemia Ferropenic
• Risk of Hemoconcentration (Iron Levels >130g/L)

Interventions

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

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

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.

Sponsors & Collaborators

• University Rovira i Virgili

  collaborator OTHER

• Catalan Institute of Health

  collaborator OTHER_GOV

• Hospital Universitari Joan XXIII de Tarragona.

  collaborator OTHER

• Carlos III Health Institute

  collaborator OTHER_GOV

• Victoria Arija Val

  lead OTHER

Principal Investigators

• 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

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-07-10

Primary Completion

2017-01-30

Completion

2017-01-30

Countries

• Spain

Study Locations