Iron supplementation in early infancy

Efficacy of iron supplementation from 90 to120 days of age to prevent development of iron deficiency anemia by 6months- A single blinded randomised controlled trial. - ESII

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/04/018460

Enrollment

144

Registered

2019-04-08

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

None listed

Interventions

Intervention1: EARLY IRON SUPPLEMENTATION: iron prophylaxis at dose of 20 mg per dose biweekly will be initiated from 90-120 days of age till completion of 6 months of age Control Intervention1: none:

Eligibility

Inclusion criteria

Inclusion criteria: All appropriate for gestational age exclusively breast fed apparently healthy term infants at 90-120days of age with hemoglobin >10.5gm/dl and MCV of 78fl.

Exclusion criteria

Exclusion criteria: Infants with congenital anomalies or genetic syndromes. Infants on iron supplementation already

Design outcomes

Primary

Measure	Time frame
To determine whether initiation of supplemental iron at 90-120 days of age in apparently healthy exclusively breast term appropriate for gestational age infants prevent the development of IDA at 6months of age.Timepoint: To determine whether initiation of supplemental iron at 90-120 days of age in apparently healthy exclusively breast term appropriate for gestational age infants prevent the development of IDA at 6months of age.	—

Measure

Time frame

To determine whether initiation of supplemental iron at 90-120 days of age in apparently healthy exclusively breast term appropriate for gestational age infants prevent the development of IDA at 6months of age.Timepoint: To determine whether initiation of supplemental iron at 90-120 days of age in apparently healthy exclusively breast term appropriate for gestational age infants prevent the development of IDA at 6months of age.

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Secondary

Measure	Time frame
. To determine the efficacy of iron supplementation in preventing the development of iron depletion at 6months of age. 2.To determine the efficacy of iron supplementation in preventing the development of iron deficient erythropoiesis at 6months of age. 3.To evaluate the change in hemoglobin, ferritin and transferrin saturation levels between the age 90 to 120 days and 6 months.Timepoint: 6 months of age	—

Measure

Time frame

. To determine the efficacy of iron supplementation in preventing the development of iron depletion at 6months of age. 2.To determine the efficacy of iron supplementation in preventing the development of iron deficient erythropoiesis at 6months of age. 3.To evaluate the change in hemoglobin, ferritin and transferrin saturation levels between the age 90 to 120 days and 6 months.Timepoint: 6 months of age

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Countries

India

Contacts

Public ContactSelva manoj kumar

JIPMER

gr_jaikumar@yahoo.in8196800157

Outcome results