Effectiveness of Adaptation of the Dose of Iron Supplementation in Pregnancy on Maternal-child Health. (ECLIPSES)
Status:
Completed
Trial end date:
2017-01-30
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Victoria Arija Val
Collaborators:
Carlos III Health Institute Catalan Institute of Health Hospital Universitari Joan XXIII de Tarragona. University Rovira i Virgili