HyperbilirubinemiaNCT07098234
Effect of Vitamin-D as an Adjuvant to Phototherapy in Reduction of Indirect Serum Bilirubin
A study testing Vitamin D3 and Phototherapy in people with Hyperbilirubinemia, run by Muhammad Aamir Latif at 1 site in Pakistan.
Trial summary
The study aimed at filling the gaps by evaluating the effectiveness of vitamin-D as an adjuvant to phototherapy in reduction of indirect serum bilirubin among neonates with exaggerated physiological hyperbilirubinemia. Read more about this study
- Who is it for?
- Ages 3 to 8 days
- Conditions the study is for
- Hyperbilirubinemia
- What is being tested?
- Vitamin D3 and Phototherapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jul 2022to 31 Dec 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 8 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborns of any gender
- Age of 3rd day of life to 8th day of life
- Gestation age ≥37 to ≤42 weeks
- Total serum bilirubin level more than 12.9 mg/dL
- Weight > 2.5 kg
Who cannot join
- Congenital defects (on physical examination)
- Large for gestational age infant
- Rh Incompatibility (were excluded on basis of blood grouping of mother and baby)
- ABO Incompatibility (were excluded on basis of blood grouping of mother and baby)
- Neonatal sepsis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of the Effect of Vitamin-D as an Adjuvant to Phototherapy in Reduction of Indirect Serum Bilirubin Among Neonates With Exaggerated Physiological Hyperbilirubinemia.
The study aimed at filling the gaps by evaluating the effectiveness of vitamin-D as an adjuvant to phototherapy in reduction of indirect serum bilirubin among neonates with exaggerated physiological hyperbilirubinemia.
Read the detailed description
If vitamin-D has been found effective as an adjuvant to phototherapy in the treatment of exaggerated physiological hyperbilirubinemia, it may help to reduce the serum bilirubin level rapidly. It may also reduce the complications by shortening the duration of phototherapy to offer better patient compliance and better patient outcomes.
- Conditions
- Hyperbilirubinemia
- Being tested
- Vitamin D3, Phototherapy
- Medical subject headings
- Hyperbilirubinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Drug
Neonates were given vitamin D3 (cholecalciferol) in an oral drops formulation (400 IU/drop), at a dose of 400 IU once a day until the serum bilirubin level was out of phototherapy range or a maximum of 72 hours as an adjuvant therapy to phototherapy.
PhototherapyProcedure or surgery
Neonates received only phototherapy until the serum bilirubin level was out of phototherapy range or a maximum of 72 hours.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 group | Experimental | Neonates were given vitamin D3 (cholecalciferol) in an oral drops formulation (400 IU/drop), at a dose of 400 IU once a day for 72 hours as an adjuvant therapy to phototherapy. Receives: Drug: Vitamin D3; Procedure: Phototherapy |
| Phototherapy group | Experimental | Neonates received only phototherapy for 72 hours. Receives: Procedure: Phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bilirubin reduction comparison
Net reductions in bilirubin levels in two groups after 72 hours were compared.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start1 Jul 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperbilirubinemiaStudies 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
- Masking
- None (open label)
- Enrolment
- 90 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
- Hafsah Naz, Principal investigator, Mayo Hospital, Lahore, PakistanMuhammad Ashfaq, Principal investigator, Mayo Hospital, Lahore, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07098234
- Sponsor's protocol ID
- Dr-Hafsah-LHR
- Status last verified
- Aug 2025
- First submitted
- 25 Jul 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data can be shared on a reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Effect of Vitamin-D as an Adjuvant to Phototherapy in Reduction of Indirect Serum Bilirubin Among Neonates With Exaggerated Physiological Hyperbilirubinemia.
- ClinicalTrials.gov ID
- NCT07098234
- Acronym / sponsor ID
- Dr-Hafsah-LHR
- Conditions
- Hyperbilirubinemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Muhammad Aamir LatifUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 1 Aug 2025 (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.
The study aimed at filling the gaps by evaluating the effectiveness of vitamin-D as an adjuvant to phototherapy in reduction of indirect serum bilirubin among neonates with exaggerated physiological hyperbilirubinemia.
Detailed description
If vitamin-D has been found effective as an adjuvant to phototherapy in the treatment of exaggerated physiological hyperbilirubinemia, it may help to reduce the serum bilirubin level rapidly. It may also reduce the complications by shortening the duration of phototherapy to offer better patient compliance and better patient outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 group | Experimental | Drug: Vitamin D3, Procedure: PhototherapyNeonates were given vitamin D3 (cholecalciferol) in an oral drops formulation (400 IU/drop), at a dose of 400 IU once a day for 72 hours as an adjuvant therapy to phototherapy. |
| Phototherapy group | Experimental | Procedure: PhototherapyNeonates received only phototherapy for 72 hours. |
Who may qualify
- Ages
- 3 to 8 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Newborns of any gender
- Age of 3rd day of life to 8th day of life
- Gestation age ≥37 to ≤42 weeks
- Total serum bilirubin level more than 12.9 mg/dL
- Weight > 2.5 kg
Key exclusion criteria (5 listed)
- Congenital defects (on physical examination)
- Large for gestational age infant
- Rh Incompatibility (were excluded on basis of blood grouping of mother and baby)
- ABO Incompatibility (were excluded on basis of blood grouping of mother and baby)
- 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 D3Neonates were given vitamin D3 (cholecalciferol) in an oral drops formulation (400 IU/drop), at a dose of 400 IU once a day until the serum bilirubin level was out of phototherapy range or a maximum of 72 hours as an adjuvant therapy to phototherapy. | Drug | Vitamin D3 group |
| PhototherapyNeonates received only phototherapy until the serum bilirubin level was out of phototherapy range or a maximum of 72 hours. | Procedure or surgery | Phototherapy group, Vitamin D3 group |
Primary outcome
Bilirubin reduction comparison
Time frame: 72 hours
Net reductions in bilirubin levels in two groups after 72 hours were compared.
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 8 Aug 2025.
- Individual participant dataSharing planned: No. The data can be shared on a reasonable request.
Related trials for Hyperbilirubinemia
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Paternal Involvement in Nursing Guidance and Breastfeeding Self-Efficacy in Mothers of High-Risk Newborns
Prematurity, Low Birth Weight
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Efficacy of Bifidobacterium Animalis Subsp. Lactis in the Treatment of Indirect Hyperbilirubinemia in Term Neonates
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Recruiting
The Effect of Kangaroo Care on Pain in Infants Receiving Phototherapy
Procedural Pain, Neonatal Hyperbilirubinemia
Enrolling by invitation
Hat-Type Glasses Intervention in Phototherapy-Related Newborns
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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.
Hafsah Naz principal investigator
Mayo Hospital, Lahore, Pakistan
Muhammad Ashfaq principal investigator
Mayo Hospital, Lahore, Pakistan
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 D3 and Phototherapy in people with Hyperbilirubinemia, 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 5 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 8 Aug 2025. 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?
Bilirubin reduction comparison (time frame: 72 hours). 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 8 Aug 2025; AzTrials last refreshed its copy on 8 Nov 2026.