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Prevention of Myopia of Prematurity by Calcium Supplementation

NCT00892476 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2012-12-05

No results posted yet for this study

Summary

The purpose of this study is to determine if supplementation of calcium by the enteral route (gut feeding) to extremely low birth weight infants will lead to less myopia (nearsightedness) at 6-12 months postnatal age.

Secondly, the study will determine if calcium supplementation is well tolerated, if it reduces the molding of these premature infants' heads, and if it decreases myopia at the 18-22 month postnatal age visit.

Conditions

  • Myopia

Interventions

DIETARY_SUPPLEMENT

Calcium Supplementation

Ca-gluconate powder (molar weight 430.4 g) will be measured with household measuring spoons and added to the feeding mixtures as follows: Amount of feeding Actual Weight \< 1000 g Actual Weight \< 1000 g 25 ml ¼ tsp 1/8 tsp 50 ml ½ tsp ¼ tsp 100 ml 1 tsp ½ tsp 200 ml 2 tsp 1 tsp

OTHER

Standard of Care

Infants are feed breast milk with fortifier or 24 cal/oz formula per standard of care

Sponsors & Collaborators

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Waldemar Carlo, MD · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
14 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-02-28
Primary Completion
2004-06-30
Completion
2008-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00892476 on ClinicalTrials.gov