Neonatal JaundiceNCT06650293
Effect of Vitamin D Supplementation as Adjuvant Therapy in Neonatal Jaundice in Combination With Phototherapy
A study testing Vitamin D in people with Neonatal Jaundice, run by Muhammad Aamir Latif at 1 site in Pakistan.
Trial summary
Neonatal jaundice frequently occur during initial week of life. Neonatal jaundice is one of the leading causes of hospital admission and readmission. Some studies have suggested that the healthy newborns with hyperbilirubinemia outside the physiological range have notably reduced serum vitamin D levels. Read more about this study
- Who is it for?
- Ages 3 to 28 days
- Conditions the study is for
- Neonatal Jaundice
- What is being tested?
- Vitamin D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 10 May 2022to 10 Nov 2022
- Phase
- Interventional
- 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 3 to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Both genders
- Admitted between 3-28 days of age.
- Indirect hyperbilirubinemia with TSB levels between 14-20 mg/dL
- Born via either cesarean or vaginal delivery
- Birth weight greater than 2500 grams
Who cannot join
- Prior phototherapy treatment
- Preterm birth (gestational age below 37 weeks).
- SpO2 < 95% at the time of admission
- Severe respiratory distress or failure
- Neonatal sepsis
- Congenital anomalies
- Parents/guardians unwilling to let their neonates be part of this study.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Pediatric Medicine Department University of Child Health Sciences, Children's Hospital Lahore
Lahore
About this study
Neonatal jaundice frequently occur during initial week of life. Neonatal jaundice is one of the leading causes of hospital admission and readmission. Some studies have suggested that the healthy newborns with hyperbilirubinemia outside the physiological range have notably reduced serum vitamin D levels. This deficiency is inversely associated with neonatal hyperbilirubinemia, suggesting that low vitamin D levels could be a potential risk factor for jaundice among neonates.
- Conditions
- Neonatal Jaundice
- Being tested
- Vitamin D
- Medical subject headings
- Jaundice, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
Vitamin D supplementation as vitamin D, 2 drops i.e., 800 IU daily for 5 days.
| Study group | Role | What they receive |
|---|---|---|
| Group-A | Experimental | Neonates receive phototherapy plus vitamin D Receives: Drug: Vitamin D |
| Group-B | No intervention | Neonates will receive only phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Serum bilirubin levels
Total Serum bilirubin levels evaluated
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start10 May 2022
- Primary completion9 Nov 2022
- Study completion10 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal JaundiceStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muhammad Aamir Latif
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muhammad Aamir Latif, RESnTEC, Institute of Research
- Investigators
- Zeeshan Afzal, FCPS, Principal investigator, Pediatric Medicine Department University of Child Health Sciences, Children's Hospital LahoreWajiha Rizwan, FCPS, Study director, Pediatric Medicine Department University of Child Health Sciences, Children's Hospital Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06650293
- Sponsor's protocol ID
- UCHSL-1
- Status last verified
- Oct 2024
- First submitted
- 18 Oct 2024
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin D Supplementation as Adjuvant Therapy in Neonatal Jaundice in Combination With Phototherapy
- ClinicalTrials.gov ID
- NCT06650293
- Acronym / sponsor ID
- UCHSL-1
- Conditions
- Neonatal Jaundice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Muhammad Aamir LatifUniversity, hospital or other
- Study start
- 10 May 2022 (actual)
- Primary completion
- 9 Nov 2022 (actual)
- Study completion
- 10 Nov 2022 (actual)
- First posted
- 21 Oct 2024 (actual)
- 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.
Neonatal jaundice frequently occur during initial week of life. Neonatal jaundice is one of the leading causes of hospital admission and readmission. Some studies have suggested that the healthy newborns with hyperbilirubinemia outside the physiological range have notably reduced serum vitamin D levels. This deficiency is inversely associated with neonatal hyperbilirubinemia, suggesting that low vitamin D levels could be a potential risk factor for jaundice among neonates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Group-A | Experimental | Drug: Vitamin DNeonates receive phototherapy plus vitamin D |
| Group-B | No intervention | –Neonates will receive only phototherapy |
Who may qualify
- Ages
- 3 to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Both genders
- Admitted between 3-28 days of age.
- Indirect hyperbilirubinemia with TSB levels between 14-20 mg/dL
- Born via either cesarean or vaginal delivery
- Birth weight greater than 2500 grams
Key exclusion criteria (7 listed)
- Prior phototherapy treatment
- Preterm birth (gestational age below 37 weeks).
- SpO2 < 95% at the time of admission
- Severe respiratory distress or failure
- Neonatal sepsis
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 |
|---|---|---|
| Vitamin DVitamin D supplementation as vitamin D, 2 drops i.e., 800 IU daily for 5 days. | Drug | Group-A |
Primary outcome
Total Serum bilirubin levels
Time frame: 5 days
Total Serum bilirubin levels evaluated
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 21 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Neonatal Jaundice
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Newborn Abdominal Massage to Prevent Hyperbilirubinemia
Newborn Jaundice
Not yet recruiting
Efficacy of Bifidobacterium Animalis Subsp. Lactis in the Treatment of Indirect Hyperbilirubinemia in Term Neonates
Indirect Hyperbilirubinemia
Not yet recruitingPhase 4
Comparison Of Fenofibrate Vs Phenobarbitone As Adjunct To Phototherapy In Reducing Total Serum Bilirubin In Indirect Hyperbilirubinemia In Neonates
Jaundice, Neonatal
Enrolling by invitation
Hat-Type Glasses Intervention in Phototherapy-Related Newborns
Neonatal Hyperbilirubinemia, Neonatal Jaundice
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.
Zeeshan Afzal, FCPS principal investigator
Pediatric Medicine Department University of Child Health Sciences, Children's Hospital Lahore
Wajiha Rizwan, FCPS study director
Pediatric Medicine Department University of Child Health Sciences, Children's Hospital Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D in people with Neonatal Jaundice, run by Muhammad Aamir Latif at 1 site in Pakistan.
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 5 inclusion and 7 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 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
Total Serum bilirubin levels (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Oct 2024; AzTrials last refreshed its copy on 8 Nov 2026.