search
Back to results

Prevention of Myopia of Prematurity by Calcium Supplementation

Primary Purpose

Myopia

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Calcium Supplementation
Standard of Care
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Myopia focused on measuring myopia, calcium supplementation, prematurity

Eligibility Criteria

1 Day - 14 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    1

    2

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Supplementation of Ca will lead to increased cycloplegic refraction at 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
    Supplementation of Ca will reduce the dolichocephalic deformation of the infants' heads as measured by the FOD/BPD index.
    Supplementation of Ca will reduce the incidence of fractures.
    Supplementation of Ca will not increase the incidence of NEC stage 2A or greater.
    Supplementation of Ca will not increase the incidence of feeding intolerance.
    Supplementation of Ca is not associated with a change in the incidence of ROP.
    Supplementation of Ca will increase bone mineral density at 36 weeks postmenstrual age (only relevant if measurement is available).

    Full Information

    First Posted
    April 30, 2009
    Last Updated
    December 4, 2012
    Sponsor
    University of Alabama at Birmingham
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00892476
    Brief Title
    Prevention of Myopia of Prematurity by Calcium Supplementation
    Official Title
    Prevention of Myopia of Prematurity by Calcium Supplementation in a Randomized Controlled Pilot Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2002 (undefined)
    Primary Completion Date
    June 2004 (Actual)
    Study Completion Date
    December 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Alabama at Birmingham

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    All infants admitted meeting the 401-1000gm birthweight and less than 14 day of age entry criteria will be screened for entry into the study. Infants may be excluded for the following: 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. Written informed consent of one parent or legal guardian must be obtained. The infants are randomized to receive unsupplemented feedings of breast milk or formula, or feedings supplemented with Ca-gluconate as outlined below. Randomization will be stratified into the following groups: 401-750 g and 751-1000 g and performed according to a balanced block scheme with variable block size (2-6) using sealed opaque envelopes. Total parenteral nutrition is given by nursery unit standards. Infant positioning is done by nursery unit standards. Feeding mixtures: Supplementation is started when enteral feeding amounts to 100 ml/kg. At that time, fortification is also introduced in infants receiving breast milk. Fortified human milk or 24 cal/oz formula, e.g. Similac Special Care 24 (SSC24), is used in all participating infants. Human milk is fortified with 1 pk Enfamil human milk fortifier per 25 ml (BMHMF). Control group: Fortified human milk or 24 cal/oz formula. Supplemented group: Ca-gluconate powder (molar weight 430.4 g) will be measured with household measuring spoons (e.g. Rubbermaid (R)) and added to the feeding mixtures. One eye exam will be performed at 6-12 months during routine follow-up visit. A second eye exam will be performed at 18-2 months during a follow-up visit which is part of the NICHD newborn follow-up clinic. Head measurements, specifically, front-to-back and side-to-side will be measured at randomization, 36 weeks postmenstrual age or discharge, whichever occurs first, and during the follow up visits. Urinalysis will be collected weekly.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myopia
    Keywords
    myopia, calcium supplementation, prematurity

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    99 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Infants receive supplemental calcium in their 24 cal/oz formula or fortified breast milk.
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    Infants will receive fortified breast milk or 24 cal/oz formula
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Calcium Supplementation
    Other Intervention Name(s)
    USP grade Calcium gluconate powder from Sigma Chemical Company (Cat # C-8231, St. Louis, MO)
    Intervention Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    Standard of Care
    Intervention Description
    Infants are feed breast milk with fortifier or 24 cal/oz formula per standard of care
    Primary Outcome Measure Information:
    Title
    Supplementation of Ca by the enteral route to ELBW infants will lead to an increased cycloplegic refraction at 6-12 months postnatal age.
    Time Frame
    6-12 months postnatal age
    Secondary Outcome Measure Information:
    Title
    Supplementation of Ca will lead to increased cycloplegic refraction at 18-22 months corrected age.
    Time Frame
    18-22 months corrected age
    Title
    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
    Time Frame
    6 months postnatal age to 18-22 months corrected age
    Title
    Supplementation of Ca will reduce the dolichocephalic deformation of the infants' heads as measured by the FOD/BPD index.
    Time Frame
    18-22 months corrected age
    Title
    Supplementation of Ca will reduce the incidence of fractures.
    Time Frame
    birth to discharge
    Title
    Supplementation of Ca will not increase the incidence of NEC stage 2A or greater.
    Time Frame
    birth to discharge
    Title
    Supplementation of Ca will not increase the incidence of feeding intolerance.
    Time Frame
    birth to discharge
    Title
    Supplementation of Ca is not associated with a change in the incidence of ROP.
    Time Frame
    birth to full vascularization of the retina
    Title
    Supplementation of Ca will increase bone mineral density at 36 weeks postmenstrual age (only relevant if measurement is available).
    Time Frame
    36 weeks postmenstrual age

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Day
    Maximum Age & Unit of Time
    14 Days
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Infants with a birthweight of 401 - 1000 g and postnatal age less than 14 days Exclusion Criteria: 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Waldemar Carlo, MD
    Organizational Affiliation
    University of Alabama at Birmingham
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21865980
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

    Prevention of Myopia of Prematurity by Calcium Supplementation

    We'll reach out to this number within 24 hrs