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Prevention of Myopia of Prematurity by Calcium Supplementation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00892476
Recruitment Status : Completed
First Posted : May 4, 2009
Last Update Posted : December 5, 2012
Sponsor:
Information provided by (Responsible Party):
University of Alabama at Birmingham

Tracking Information
First Submitted Date  ICMJE April 30, 2009
First Posted Date  ICMJE May 4, 2009
Last Update Posted Date December 5, 2012
Study Start Date  ICMJE February 2002
Actual Primary Completion Date June 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 1, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00892476 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2009)
  • Supplementation of Ca will lead to increased cycloplegic refraction at 18-22 months corrected age. [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 18-22 months corrected age ]
  • Supplementation of Ca will reduce the incidence of fractures. [ Time Frame: birth to discharge ]
  • Supplementation of Ca will not increase the incidence of NEC stage 2A or greater. [ Time Frame: birth to discharge ]
  • Supplementation of Ca will not increase the incidence of feeding intolerance. [ Time Frame: birth to discharge ]
  • Supplementation of Ca is not associated with a change in the incidence of ROP. [ Time Frame: birth to full vascularization of the retina ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention of Myopia of Prematurity by Calcium Supplementation
Official Title  ICMJE Prevention of Myopia of Prematurity by Calcium Supplementation in a Randomized Controlled Pilot Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Myopia
Intervention  ICMJE
  • 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 Name: USP grade Calcium gluconate powder from Sigma Chemical Company (Cat # C-8231, St. Louis, MO)
  • Other: Standard of Care
    Infants are feed breast milk with fortifier or 24 cal/oz formula per standard of care
Study Arms  ICMJE
  • Experimental: 1
    Infants receive supplemental calcium in their 24 cal/oz formula or fortified breast milk.
    Intervention: Dietary Supplement: Calcium Supplementation
  • Active Comparator: 2
    Infants will receive fortified breast milk or 24 cal/oz formula
    Intervention: Other: Standard of Care
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 1, 2009)
99
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date June 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 14 Days   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00892476
Other Study ID Numbers  ICMJE F010613009
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Waldemar Carlo, MD University of Alabama at Birmingham
PRS Account University of Alabama at Birmingham
Verification Date July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP