MyopiaPhase 1NCT00892476
Prevention of Myopia of Prematurity by Calcium Supplementation
A Phase 1 study testing Calcium Supplementation in people with Myopia, run by University of Alabama at Birmingham.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 14 days
- Conditions the study is for
- Myopia
- What is being tested?
- Calcium Supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- No sites listed yet
- Study dates
- Feb 2002to Dec 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 14 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants with a birthweight of 401 - 1000 g and postnatal age less than 14 days
Who cannot join
- 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.
About this study
Official title: Prevention of Myopia of Prematurity by Calcium Supplementation in a Randomized Controlled Pilot Trial
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.
Read the 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.
- Conditions
- Myopia
- Being tested
- Calcium Supplementation, Standard of Care
- Keywords
- myopia, calcium supplementation, prematurity
- Medical subject headings
- Myopia, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium SupplementationDietary supplement
Also called USP grade Calcium gluconate powder from Sigma Chemical Company (Cat # C-8231, St. Louis, MO)
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
Standard of CareOther
Infants are feed breast milk with fortifier or 24 cal/oz formula per standard of care
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Infants receive supplemental calcium in their 24 cal/oz formula or fortified breast milk. Receives: Dietary Supplement: Calcium Supplementation |
| 2 | Active comparator | Infants will receive fortified breast milk or 24 cal/oz formula Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Supplementation of Ca by the enteral route to ELBW infants will lead to an increased cycloplegic refraction at 6-12 months postnatal age.
Measured: 6-12 months postnatal age
Secondary outcomes (8)
Supplementation of Ca will lead to increased cycloplegic refraction at 18-22 months corrected age.
Measured: 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
Measured: 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.
Measured: 18-22 months corrected age
Supplementation of Ca will reduce the incidence of fractures.
Measured: birth to discharge
Supplementation of Ca will not increase the incidence of NEC stage 2A or greater.
Measured: birth to discharge
Supplementation of Ca will not increase the incidence of feeding intolerance.
Measured: birth to discharge
Supplementation of Ca is not associated with a change in the incidence of ROP.
Measured: 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).
Measured: 36 weeks postmenstrual age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2009 (estimated)
- Study startFeb 2002
- Primary completionJun 2004
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Waldemar Carlo, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00892476
- Sponsor's protocol ID
- F010613009
- Status last verified
- Jul 2010
- First submitted
- 30 Apr 2009
- Last updated
- 5 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 21865980
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Myopia of Prematurity by Calcium Supplementation in a Randomized Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT00892476
- Acronym / sponsor ID
- F010613009
- Conditions
- Myopia
- Keywords
- myopia, calcium supplementation, prematurity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Feb 2002
- Primary completion
- Jun 2004 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 4 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Calcium SupplementationInfants receive supplemental calcium in their 24 cal/oz formula or fortified breast milk. |
| 2 | Active comparator | Other: Standard of CareInfants will receive fortified breast milk or 24 cal/oz formula |
Who may qualify
- Ages
- 1 day to 14 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants with a birthweight of 401 - 1000 g and postnatal age less than 14 days
Key exclusion criteria (8 listed)
- Major congenital malformations including
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium SupplementationAlso: USP grade Calcium gluconate powder from Sigma Chemical Company (Cat # C-8231, St. Louis, MO)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 | Dietary supplement | 1 |
| Standard of CareInfants are feed breast milk with fortifier or 24 cal/oz formula per standard of care | Other | 2 |
Primary outcome
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
8 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2012.
- Derived from this study: PubMed 21865980Carroll 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Waldemar Carlo, MD principal investigator
University of Alabama at Birmingham
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Calcium Supplementation in people with Myopia, run by University of Alabama at Birmingham.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00892476, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2012.