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NCT04050488
Zinc Supplementation on Very Low Birth Weight Infant
Phase 4 trial testing Zinc Sulfate in Early-Onset Sepses, Neonatal in 364 participants. Status unknown.
31 July 2020
Quick facts
| Lead sponsor | Fakultas Kedokteran Universitas Indonesia |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 364 |
| Start date | 20 August 2019 |
| Primary completion | 31 July 2020 |
| Estimated completion | 31 July 2020 |
Drugs / interventions tested
- Zinc Sulfate (ZINC SULFATE) — full drug profile →
- Placebos — full drug profile →
Conditions studied
- Early-Onset Sepses, Neonatal — all drugs for Early-Onset Sepses, Neonatal →
- Periventricular Haemorrhage Neonatal — all drugs for Periventricular Haemorrhage Neonatal →
- Bronchopulmonary Dysplasia — all drugs for Bronchopulmonary Dysplasia →
- Retinopathy of Prematurity — all drugs for Retinopathy of Prematurity →
Sponsor
Fakultas Kedokteran Universitas Indonesia — full company profile →
Who can join
Under 3 Days, any sex, with Early-Onset Sepses, Neonatal or Periventricular Haemorrhage Neonatal. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Premature birth is a major cause of neonatal death in addition to neonatal asphyxia and infections. Early in life, premature babies must get aggressive nutrition so that there is no extrauterine growth restriction (EUGR) in the Intrauterine Growth Restriction (IUGR) group compared to the non-IUGR group. Other factors that also play a role are long episodes of fasting, the fulfillment of nutrition (macro and micronutrients) from the start, time to start breastfeeding (ASI), duration of parenteral total administration, the incidence of respiratory distress syndrome and incidence of necrotizing enterocolitis. Zinc is one of the micronutrients which is very risky for deficiency in premature babies. Babies with zinc deficiency experience growth disorders as much as 67%. In India, infants who received zinc supplementation increased after being given 10 days of zinc supplementation and lower mortality rates in the group with supplementation. Very low birth weight babies and bronchopulmonary dysplasia who received zinc supplementation during the week showed good clinical progress and the growth rate also increased. The investigators believe this study has the potential for decreasing infant mortality from its current level and can be a growth indicator for preterm babies.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Enteral zinc supplementation for prevention of morbidity and mortality in preterm neonates.
Staub E, Evers K, Askie LM. · · 2021 · cited 25× · PMID 33710626 · DOI 10.1002/14651858.cd012797.pub2 -
Enteral Bioactive Factor Supplementation in Preterm Infants: A Systematic Review.
Mank E, Naninck EFG, Limpens J, van Toledo L, et al · · 2020 · cited 7× · PMID 32987621 · DOI 10.3390/nu12102916
Verify or expand the search:
- PubMed search for NCT04050488
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Zinc Sulfate
Trials testing the same drug.
- NCT06433674 — Enteral Zinc Supplementation in Very Low Birth Weight Infants · Phase 3 · not yet recruiting
- NCT06556511 — Efficacy Of Zinc Towards The Outcome on Children With Sepsis · NA · completed
- NCT04370782 — Hydroxychloroquine and Zinc With Either Azithromycin or Doxycycline for Treatment of COVID-19 in Outpatient Setting · Phase 4 · completed
- NCT03923829 — The Effect of Zinc on the Gingival Crevicular Fluid Level of Total Oxidant Capacity in Type 2 Diabetic Patients · NA · unknown
- NCT03404310 — Zinc Sulfate for Human Papillomavirus (HPV) · NA · terminated
Other Fakultas Kedokteran Universitas Indonesia trials
Trials by the same sponsor.
- NCT07308275 — Longitudinal Evaluation of Direct Neurotization Technique in Breast Reconstruction With Fully Autologous Components · NA · not yet recruiting
- NCT07156786 — N-Acetylcysteine Roles in Preserving Renal Function Measured by Urinary KIM-1 (Kidney Injury Molecule-1) and Serum Creat · Phase 2, PHASE3 · not yet recruiting
- NCT06521957 — Effectiveness of CBT in Improving Psycho-Neuro-Endocrine Factors in Women Following In Vitro Fertilization Program · NA · recruiting
- NCT05451433 — The Effect of Saccharomyces Boulardii in Clinical Presentation and Quality of Life Patient With IBS · NA · unknown
- NCT05215301 — Assessment of Multidimensional Voice Program (MDVP) Parameters in Workers · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04050488 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fakultas Kedokteran Universitas Indonesia
- Last refreshed: 15 August 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04050488.
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