Efficacy of copper supplementation in anemia and morbidity due to diarrhea in Peruvian infants

Not Applicable

• Conditions: -D649 Anaemia, unspecified-R19; Anaemia, unspecified; D649; R19

• Registration Number: PER-002-06
• Lead Sponsor: ASOCIACION INTERNACIONAL DEL COBRE (ICA) CHILE,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-03-07
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Infants 6-11 months of age.
2. Full term, with a weight> 2500 g.
3. Healthy subjects.
4. Subjects with anemia (Hb <11.0 gr / L).
5. Residents in Villa El Salvador, Lima.
6. That the parents sign the informed consent form.

Exclusion Criteria

1. Serious, chronic diseases.
2. Congenital malformations.
3. Severe malnutrition (P / T < -2DE).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Clinical evaluation In the case of diarrhea, the following definition must be met: presence of 3+ liquid stools, or a deposition with blood, in 24 hours, each episode of diarrhea must be separated from at least 2 days without diarrhea. In the case of anemia, the following definition must be met: hemoglobin <11.0 g / L.<br>Measure:Incidence of Diarrhea. Incidence of Anemia.<br>Timepoints:Visits during months 1, 2, 3, 4, 5 and 6.<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:Hemoglobin will be measured directly with a portable hemoglobinometer (Hemocue, Angehollm, Sweden).<br>Zinc and copper will be measured by atomic absorption spectrometry (AAS).<br>Ferritin will be measured by ELISA.<br>Hematocrit by the microhematocrit method using standard procedures.<br>Measure:Changes in hemoglobin, serum ferritin, zinc and copper in serum.<br>Timepoints:Hb and Hto: Months 1, 3 and 6.<br>Zinc, Copper and Ferritin: Months 1 and 6.<br>;<br>Outcome name:Z Score of Height / Age, Weight / Age, Weight / Size.<br>Cephalic perimeter, arm and subcutaneous folds (triceps, biceps and subscapular).<br>Measure:Growth indicators.<br>Timepoints:Months 1 and 6.<br>