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Vitamin Supplement
Vitamin D Supplementation for Premature Birth
Phase 1 & 2
Recruiting
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 40 - 120 days
Awards & highlights
Study Summary
This trial tests if higher vitamin D intake helps extremely preterm babies. They'll get either high or low doses & be tracked for health outcomes.
Who is the study for?
This trial is for extremely preterm infants born at a gestational age of 28 weeks or less. Infants with terminal illnesses where life support is limited, or those with major congenital anomalies cannot participate.Check my eligibility
What is being tested?
The study tests the effects of early vitamin D supplementation in very premature babies. They are randomly assigned to receive either high doses (intervention group) or low doses (control group) during their first two weeks after birth.See study design
What are the potential side effects?
Potential side effects from vitamin D supplementation could include hypercalcemia (high calcium levels), which might affect kidney function and lead to symptoms like nausea, vomiting, and frequent urination.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0 - 120 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0 - 120 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Oscillometry
Morbidity - disease rate
Secondary outcome measures
Bronchopulmonary Dysplasia
Side effects data
From 2013 Phase 3 trial • 122 Patients • NCT014735897%
Nasopharyngitis
6%
Prostatitis
5%
Constipation
5%
Osteoporosis
5%
Insomnia
5%
Arthralgia
5%
Back pain
3%
Asthenia
3%
Nausea
3%
Hypoaesthesia
3%
Myalgia
2%
Cellulitis
2%
Thirst
2%
Presyncope
2%
Chondropathy
2%
Palpitations
2%
Subdural haematoma
2%
Fall
2%
Dacryostenosis acquired
2%
Abdominal pain lower
2%
Dental caries
2%
Diarrhoea
2%
Diverticulum intestinal
2%
Faecaloma
2%
Gastritis atrophic
2%
Oedema peripheral
2%
Pain
2%
Pyrexia
2%
Ear infection
2%
Oral candidiasis
2%
Wound infection
2%
Contusion
2%
Humerus fracture
2%
Laceration
2%
Blood alkaline phosphatase increased
2%
Hyperlipidaemia
2%
Pain in extremity
2%
Spinal column stenosis
2%
Trigger finger
2%
Dizziness
2%
Headache
2%
Mental status changes
2%
Urinary retention
2%
Dyshidrotic eczema
2%
Hypertrophic scar
2%
Rash
2%
Thrombosis
2%
Arrhythmia
2%
Gastrooesophageal reflux disease
2%
Hiatus hernia
2%
Respiratory failure
2%
Decreased appetite
2%
Pneumonia
2%
Oral herpes
2%
Bradyarrhythmia
2%
Supraventricular tachycardia
2%
Vertigo
2%
Cholelithiasis
2%
Hypoglycaemia
2%
Musculoskeletal pain
2%
Osteoarthritis
2%
Neuralgia
2%
Paraesthesia
2%
Parkinson's disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Teriparatide
Placebo Follow-up
Teriparatide Follow-up
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Vitamin D groupExperimental Treatment1 Intervention
Group II: Control groupPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vitamin D supplementation
2022
Completed Phase 4
~2250
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,590 Previous Clinical Trials
2,281,356 Total Patients Enrolled
22 Trials studying Premature Birth
27,092 Patients Enrolled for Premature Birth
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My infant has a major birth defect.
Research Study Groups:
This trial has the following groups:- Group 1: Vitamin D group
- Group 2: Control group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who meets the eligibility criteria for participating in this research endeavor?
"This medical experiment requires the enrollment of 126 infants who experienced premature birth and are aged between one day to four days. Most importantly, those hoping to participate must have a gestational age of 28 weeks or lower."
Answered by AI
Does the participant criteria for this trial extend to those younger than 55 years old?
"In accordance with the study's enrollment regulations, participants must be between 1 and 4 days of age."
Answered by AI
Are there still vacancies for individuals to join this trial?
"A review of clinicaltrials.gov indicates that this medical study, which was initially put online on January 1st 2023 and last edited on November 9th 2022, is not presently accepting applications for participation. Nevertheless, there are still 272 other trials actively recruiting at the time of writing."
Answered by AI
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