Vitamin A and Very Low Birthweight Babies (VitAL)

NCT00417404 | Completed Phase 4 DMC

• 2 other identifiers: RNO50BO17CZB/4/316
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 2

Brief Summary

Vitamin A is important for the development of healthy eyes and lungs. Very low birth weight premature babies have low body stores of vitamin A and are prone to diseases of the eye and lungs. Previous work has shown that intramuscular (IM) vitamin A reduces the number of babies who require prolonged oxygen therapy, and may also reduce the number of babies affected by retinopathy of prematurity (ROP)). There is also some evidence that the conjunctiva shows signs of deficiency of vitamin A in premature infants, particularly those who develop ROP. Our own work here in Glasgow suggests that, compared to babies born at full term, premature babies' eyes are less sensitive to light and we believe that this may reflect shortage of vitamin A in the eye. This study will examine the effects upon the eye of giving extra intramuscular vitamin A to very low birth weight, premature infants. We will also measure blood levels of vitamin A and calculate liver stores of this nutrient.

Conditions

Preterm Birth; Retinopathy of Prematurity

Keywords

preterm; nutrition; vitamin A; electroretinogram; conjunctiva; vitamin A status; conjunctival health

Outcome Measures

Primary Outcomes (1)

• retinal function at 36 corrected weeks

  36 corrected weeks

Secondary Outcomes (2)

• plasma levels of vitamin A at birth, 7 and 28 days

  birth, 7 and 28 days

• hepatic stores of vitamin A at 36 corrected weeks

  36 corrected weeks

Study Arms (2)

vitamin A

ACTIVE COMPARATOR

Drug: Aquasol A

sham injection

SHAM COMPARATOR

Other: sham injection

Interventions

aquasol A DRUG

IM Aquasol A 10,000IU three times weekly

Also known as: vitamin A

vitamin A

sham injection OTHER

sham injection

sham injection

Eligibility Criteria

• Age: 24 Hours - 72 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants born at \< 32 completed weeks gestation and/or weighing \< 1501 grams birth weight who have been admitted to either Princess Royal Maternity or Queen Mother's Hospital within the first 24 hours of life.

You may not qualify if:

• Congenital ocular abnormality

Sponsors & Collaborators

• Glasgow Royal Infirmary: lead
• Chief Scientist Office of the Scottish Government: collaborator

Study Sites (2)

Queen Mother's Hospital

Glasgow, G3 8SJ, United Kingdom

Location

Princess Royal Maternity

Glasgow, G31 2ER, United Kingdom

Location

MeSH Terms

Conditions

Premature Birth; Retinopathy of Prematurity

Interventions

Vitamin A; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors

Study Officials

• Helen Mactier, MD

  Glasgow Royal Infirmary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 29, 2006
• First Posted: January 1, 2007
• Study Start: January 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: June 25, 2010

Record last verified: 2010-06

Locations

GB (2)