RecruitingPhase 3ACTRN12612000823875

Zinc supplementation in very low birth weight neonates

Zinc supplementation and neonatal morbidity : a randomized, placebo-controlled study in very low birth weight neonates

Sponsor

“V.Betania” Evangelic Hospital of Naples

Enrollment

200 participants

Start Date

Feb 1, 2009

Study Type

Interventional

Conditions

Morbidity in very low birth weight neonates Intraventricular hemorrhage

Summary

There are many evidences that zinc may be essential for brain, pulmonary and intestinal development and function, as well as for growth, in the fetus and child. Preterm infants have a high risk of zinc deficiency. In this study we will aimed to investigate the efficacy of zinc supplementation in reducing morbidity of preterm neonates related to neurological, respiratory and intestinal complications.

Eligibility

Sex: Both males and femalesMin Age: 1 WeeksMax Age: 4 Weekss

Inclusion Criteria1

Newborns with birth weight 401-1500 g or gestational age 24-32 weeks, consecutively observed in Neonatal Intensive Care Units

Exclusion Criteria1

congenital or maternal infections, immunodeficiency, malformations, syndrome, genetic defects, evidence of infections and NEC before enrolment, critically ill condition (blood pH < 6.8, or hypoxia with persistent bradycardia for at least 1 hour), and hospitalization less than 1 week

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

Active treatment consist in zinc at dosage of 10 mg/d associated to other vitamins. We used commercial zinc preparation available on the market as drops. Treatment was started at 7 d of life until discharge from the hospital. Other vitamins contained in the preparation were (pro dose)folates (120 mcg), vit. B12 (0.6 mcg) and Vit D3 (400 UI), vit. C (60 mg), vit. E (6 mg), vit. A (480 mcg). To reach Recommended Dietary Allowance (RDA) for folates, vit. B12, D3, C, E, A, and B group, all subjects were supplemented daily with folates (56 mcg/Kg), vit B12 (0.3 mcg/Kg), vit. D3 (10 UI/Kg), vit. C (25 mg/Kg), E (2.8 mg/Kg), A (500 mcg/Kg), and B group (B1 0.35 mg/Kg, B2 0.15 mg/Kg, B6 0.18 mg/Kg, niacin 6.8 mg/Kg, and biotin 6 mcg) intravenously when in parenteral nutrition. When full enteral feeding was achieved the RDA for folates, vit B12, vit. D3, vit. C, E, A, and B group were reached in all subjects considering that preterm formula used during the study contained folates (30 mcg), vit B12 (0.2 mcg), vit. D3 (10 UI), vit. C (20 mg/Kg), E (2.4 mg), A (180 mcg), and B group (B1 0.19 mg/Kg, B2 0.30 mg/Kg, B6 0.135 mg/Kg, niacin 1.1 mg/Kg, and biotin 5.5 mcg) per 100 ml, and that all subject were supplemented daily with vit D3 (400 UI) per os. In this way, RDA for zinc was obtained only in the active treatment group.