Prevention of Myopia of Prematurity by Calcium Supplementation

NCT00892476 | Completed Phase 1 DMC

• 1 other identifier: F010613009
• Study Type: interventional
• Target: 99
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

myopia; calcium supplementation; prematurity

Outcome Measures

Primary Outcomes (1)

• Supplementation of Ca by the enteral route to ELBW infants will lead to an increased cycloplegic refraction at 6-12 months postnatal age.

  6-12 months postnatal age

Secondary Outcomes (8)

• Supplementation of Ca will lead to increased cycloplegic refraction at 18-22 months corrected age.

  18-22 months corrected age

• Supplementation of Ca will lead to an increased cycloplegic refraction at 6-12 months postnatal age and at 18-22 months corrected age in infants who had no abdominal surgery or prolonged feeding intolerance

  6 months postnatal age to 18-22 months corrected age

• Supplementation of Ca will reduce the dolichocephalic deformation of the infants' heads as measured by the FOD/BPD index.

  18-22 months corrected age

• Supplementation of Ca will reduce the incidence of fractures.

  birth to discharge

• Supplementation of Ca will not increase the incidence of NEC stage 2A or greater.

  birth to discharge

Study Arms (2)

1

EXPERIMENTAL

Infants receive supplemental calcium in their 24 cal/oz formula or fortified breast milk.

Dietary Supplement: Calcium Supplementation

2

ACTIVE COMPARATOR

Infants will receive fortified breast milk or 24 cal/oz formula

Other: Standard of Care

Interventions

Calcium Supplementation DIETARY_SUPPLEMENT

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

Also known as: USP grade Calcium gluconate powder from Sigma Chemical Company (Cat # C-8231, St. Louis, MO)

1

Standard of Care OTHER

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

2

Eligibility Criteria

• Age: 1 Day - 14 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants with a birthweight of 401 - 1000 g and postnatal age less than 14 days

You may not qualify if:

• Major congenital malformations including
• complex congenital heart disease (except open ductus arteriosus, atrial and ventricular septal defects)
• pulmonary malformations
• bowel or anal stenosis or atresia
• renal dysplasias
• chromosomal anomalies
• hydrops fetalis
• bowel perforation or necrotizing enterocolitis stage 2A or greater before randomization.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Related Publications (1)

• Carroll WF, Fabres J, Nagy TR, Frazier M, Roane C, Pohlandt F, Carlo WA, Thome UH. Results of extremely-low-birth-weight infants randomized to receive extra enteral calcium supply. J Pediatr Gastroenterol Nutr. 2011 Sep;53(3):339-45. doi: 10.1097/MPG.0b013e3182187ecd.

  PMID: 21865980 DERIVED

MeSH Terms

Conditions

Myopia; Premature Birth

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Waldemar Carlo, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2009
• First Posted: May 4, 2009
• Study Start: February 1, 2002
• Primary Completion: June 1, 2004
• Study Completion: December 1, 2008
• Last Updated: December 5, 2012

Record last verified: 2010-07