Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000658516
Ethics application status
Not yet submitted
Date submitted
8/06/2015
Date registered
25/06/2015
Date last updated
25/06/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Saliva for Assessment of Vitamin A status in preterm Infants
Scientific title
Vitamin A status assessment using saliva versus blood in preterm infants.
Secondary ID [1] 286870 0
Nil
Universal Trial Number (UTN)
Trial acronym
SAVIng blood
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vitamin A deficiency 295271 0
Condition category
Condition code
Diet and Nutrition 295522 295522 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Relative Dose Response (RDR) test will be performed to assess vitamin A status. The test involves collection of blood samples of 0.5 mL each, before and five hours after a dose of vitamin A [Vitamin A Nepalm (Registered Trademark)] (Dose: 2000 IU/kg body weight) orally in a liquid solution form. In addition to the blood samples, samples of saliva will be collected using a proprietary swab specifically designed for newborn infants [Saliva Bio Infants's Swab; Salimetrics (Registered Trademark) USA]. An additional saliva sample will be collected at seven hours, as appearance of vitamin A in saliva may lag behind its appearance in blood. Collection of saliva is a painless procedure with no expected harm to the infant. Vitamin A levels will be measured in blood and saliva samples with high performance liquid chromatography which is a standard method of vitamin A measurement.
Intervention code [1] 292048 0
Treatment: Drugs
Intervention code [2] 292049 0
Diagnosis / Prognosis
Comparator / control treatment
All the study infants will receive one dose of vitamin A [Vitamin A Nepalm (Registered Trademark)] (2000 IU/kg weight of infant) orally, required for application of Relative Dose Response (RDR) test. The standard method of diagnosis (RDR) involves measurement of vitamin A in plasma just before and five hours after a dose of vitamin A. The comparison will be made between the plasma levels and saliva levels of vitamin A before and after the dose.
Control group
Active

Outcomes
Primary outcome [1] 295258 0
Comparison between plasma and saliva levels of vitamin A (Composite primary outcome)
Timepoint [1] 295258 0
Just before a dose of vitamin A and, Five and Seven hours after the dose.
Secondary outcome [1] 315206 0
Safety of vitamin A dose: All the infants will be monitored for possible adverse effect of vitamin A administration for 24 hours.
1. Palpation of anterior fontanel (AF) for raised intracranial pressure at 24 hour: AF is palpated with infant in a quite state and held in the sitting position. Normal AF is flat, flushed with the skin and soft. (Cloherty, Manual of Neonatal care 7th Ed) A tense and bulging AF may indicate vitamin A adverse effect. The infants with tense and bulging AF with no known cause will have cranial ultrasound examination.
2. Liver size palpation for hepatomegaly at 24 hours: Liver will be palpated and recorded in cm below costal margin in the mid-clavicular line. Liver function tests will be performed if hepatomegaly is observed.
3. Skin changes: Infant will be examined at 24 hours for skin changes like desquamation of skin particularly palm and sole, mouth or lip fissures.
Timepoint [1] 315206 0
For 24 hours after the dose.
Secondary outcome [2] 315405 0
Comparison of Relative Dose Response using blood (standard) versus Relative Dose Response using saliva
Timepoint [2] 315405 0
Just before a dose of vitamin A and, Five and Seven hours after the dose.

Eligibility
Key inclusion criteria
1. Preterm infants less than 30 weeks gestational age at birth.
2. Infants tolerating enteral feeds.
3. 21 to 35 days of age
Minimum age
21 Days
Maximum age
35 Days
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Infants with necrotizing enterocolitis or major congenital gastrointestinal malformation.
2. Critically unwell infants.
3. Systemic administration of corticosteroids within seven days prior to the test.
4. No parental consent.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This is a diagnostic accuracy study. 30 eligible preterm infants will be enrolled. Relative dose response (RDR) test will be carried out using blood samples (Standard method of assessment of vitamin A status) to assess vitamin A status of the infants. RDR involves measurement of plasma (blood) vitamin A level before and five hours after vitamin A dose. We will collect saliva in addition to the blood samples to investigate if saliva levels of vitamin A correlate with blood levels.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Diagnostic accuracy study comparing saliva with blood for vitamin A levels before and after enteral administration of a dose of vitamin A.
Phase
Phase 2 / Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample size calculation: Sample size calculation of 30 infants is based on a study by Saral et al (Saral Y, Coskun BK, Ozturk P, et. al. Assessment of salivary and serum antioxidant vitamins and lipid peroxidation in patients with recurrent aphthous ulceration. Tohoku J Exp Med. 2005;206:305-312) who observed a good correlation between plasma and salivary vitamin A using a sample size of 30.
The data will be statistically analyzed using SPSS statistical package (SPS, version 9.0, Chicago, IL, USA). Correlation between plasma and salivary vitamin A levels, and blood and saliva RDR values will be tested using Pearson r correlation analysis. Statistical significance will be defined as p < 0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2015
Actual
Date of last participant enrolment
Anticipated
30/11/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 3895 0
King Edward Memorial Hospital - Subiaco
Recruitment postcode(s) [1] 9788 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 291430 0
Charities/Societies/Foundations
Name [1] 291430 0
Channel 7 Telethon Trust
Country [1] 291430 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Women and Infants Research Foundation
Address
Carson House, King Edward memorial Hospital
374 Bagot Road, Subiaco, WA 6008.
Country
Australia
Secondary sponsor category [1] 290106 0
Individual
Name [1] 290106 0
Prof Jane Pillow
Address [1] 290106 0
Neonatal Paediatrics
King Edward Memorial Hospital
374 Bagot Road, Subiaco, WA 6008.
Country [1] 290106 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 292982 0
King Edward Memorial Hospital for Women
Ethics committee address [1] 292982 0
374 Bagot Road, Subiaco, WA 6008.
Ethics committee country [1] 292982 0
Australia
Date submitted for ethics approval [1] 292982 0
09/06/2015
Approval date [1] 292982 0
Ethics approval number [1] 292982 0

Summary
Brief summary
Background: Vitamin A is essential for development and growth of lungs in preterm infants. Diseases characterised by abnormal lung development such as bronchopulmonary dysplasia (BPD) may be linked to vitamin A deficiency. BPD is associated with long term breathing and developmental problems.
Very preterm infants are at risk of vitamin A deficiency. Timely evaluation of vitamin A status of preterm infants may help to assess the risk of BPD and tailor vitamin A therapy based on the infant’s vitamin A status. Current method of assessment of vitamin A is “Relative Dose Response” (RDR). RDR test involves collection of two blood samples from the infant, one before and one after a dose of vitamin A. Thus, the requirement of repeated blood sampling, which is an invasive procedure and also increases risk of anaemia, is a major disadvantage of current RDR test. Therefore, a minimally invasive method with least harm is required.
Aim: 1) To compare salivary vitamin A with blood vitamin A, and RDR using saliva with RDR using blood; 2) Assess safety of the test
Participant group: Participants will be preterm infants admitted in King Edward Memorial Hospital, less than 30 weeks gestational age at birth and 21 to 28 days of life, and tolerating milk feeds.
Project design and Methods: An informed consent will be obtained from the parents of the eligible infants. RDR test will be performed. The test involves collection of blood samples of 0.5 mL each, before and five hours after a dose of vitamin A (2000 IU/kg body weight). Along with the blood samples, samples of saliva will also be collected using proprietary swab specifically designed for infants. An additional saliva sample will be collected at seven hours, as appearance of vitamin A in saliva may lag behind its appearance in blood. Collection of saliva is a painless procedure with no expected harm to the infant. Vitamin A levels will be measured in blood and saliva samples with high performance liquid chromatography which is a standard method of vitamin A measurement. All the study infants will be monitored for 24 hours for adverse effect of vitamin A.
Expected outcomes: A study in adults showed a good correlation between salivary and blood vitamin A in adults. We expect that salivary vitamin A level will correlate with blood vitamin A in preterm infants and will be useful to assess vitamin A status of preterm infant
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 493 493 0 0
/AnzctrAttachments/368709-Vitamin A Serum – Saliva correlation in preterm infants_6 June 2015.docx

Contacts
Principal investigator
Name 57894 0
Dr Abhijeet Rakshasbhuvankar
Address 57894 0
Neonatal Paediatrics, King Edward Memorial Hospital
374 Bagot Road, Subiaco, WA 6008
Country 57894 0
Australia
Phone 57894 0
+61893401260
Fax 57894 0
+61893401266
Email 57894 0
[email protected]
Contact person for public queries
Name 57895 0
Dr Abhijeet Rakshasbhuvankar
Address 57895 0
Neonatal Paediatrics, King Edward Memorial Hospital
374 Bagot Road, Subiaco, WA 6008
Country 57895 0
Australia
Phone 57895 0
+61893401260
Fax 57895 0
+61893401266
Email 57895 0
[email protected]
Contact person for scientific queries
Name 57896 0
Dr Abhijeet Rakshasbhuvankar
Address 57896 0
Neonatal Paediatrics, King Edward Memorial Hospital
374 Bagot Road, Subiaco, WA 6008
Country 57896 0
Australia
Phone 57896 0
+61893401260
Fax 57896 0
+61893401266
Email 57896 0
[email protected]

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