FindTrial
Sign In

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-002-06
Enrollment
310
Registered
2006-03-07
Start date
2006-03-07
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

GROUP 1 Type of group
This group will be treated with 2.5 ml (1 teaspoon) of a syrup which contains: Ferrous Sulfate 10 mg. The dose will be administered every day for 6 months. Group name:GROUP 2 Type of group
This group will be treated with 2.5 ml (1 teaspoon) of a syrup which contains: Ferrous Sulfate 10 mg and Copper Sulfate 0.6 mg. The dose will be administered every day for 6 months.

Sponsors

ASOCIACION INTERNACIONAL DEL COBRE (ICA) CHILE,
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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. Measure:Incidence of Diarrhea. Incidence of Anemia. Timepoints:Visits during months 1, 2, 3, 4, 5 and 6.—

Secondary

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

Countries

Peru

Outcome results

None listed

Source: REPEC (via WHO ICTRP)