What side effects are associated with this type of intervention?

Common treatments for premature birth include Vitamin D supplementation, magnesium sulfate, and antenatal corticosteroids. Vitamin D supplementation is generally well-tolerated but can cause hypercalcemia if overdosed. Magnesium sulfate, used for neuroprotection and tocolysis, can lead to maternal side effects such as flushing, nausea, and respiratory depression. Antenatal corticosteroids, administered to enhance fetal lung maturity, may cause maternal hyperglycemia and an increased risk of infection. These treatments aim to improve neonatal outcomes but must be carefully monitored for potential side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for premature birth, focusing on reducing complications and improving outcomes. One notable treatment is magnesium sulfate, which is used for neuroprotection to reduce the risk of cerebral palsy in preterm infants. While not directly related to calcium and phosphate metabolism, magnesium sulfate plays a crucial role in stabilizing cell membranes and neuromuscular function. Other treatments include corticosteroids like betamethasone, which accelerate fetal lung development, and tocolytics such as nifedipine, which delay labor. Although Vitamin D and its analogs are primarily studied for bone health and calcium regulation, their direct application in premature birth treatment is not well-documented.

What other types of research exist?

Currently, there are no specific novel alternatives to Vitamin D mentioned in the provided context for regulating calcium and phosphate metabolism in premature birth patients. It is important to consult with a healthcare provider to explore potential treatments and ensure appropriate management of calcium and phosphate levels in preterm infants.

← Back to Search

Vitamin Supplement

Vitamin D Supplementation for Premature Birth

Phase 1 & 2

Waitlist Available

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

Summary

This trial is testing if giving very premature babies a high dose of vitamin D helps them more than a low dose. It focuses on extremely preterm infants who are fed human milk, aiming to support their bone growth and immune system.

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 - 120 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Oscillometry

Morbidity - disease rate

Secondary study objectives

Bronchopulmonary Dysplasia

Side effects data

From 2013 Phase 3 trial • 122 Patients • NCT01473589

Nasopharyngitis

Prostatitis

Constipation

Osteoporosis

Insomnia

Arthralgia

Back pain

Asthenia

Nausea

Hypoaesthesia

Myalgia

Chondropathy

Thirst

Presyncope

Cellulitis

Palpitations

Subdural haematoma

Fall

Dacryostenosis acquired

Abdominal pain lower

Dental caries

Diarrhoea

Diverticulum intestinal

Faecaloma

Gastritis atrophic

Oedema peripheral

Pain

Pyrexia

Ear infection

Oral candidiasis

Wound infection

Contusion

Humerus fracture

Laceration

Blood alkaline phosphatase increased

Hyperlipidaemia

Pain in extremity

Spinal column stenosis

Trigger finger

Dizziness

Headache

Mental status changes

Urinary retention

Dyshidrotic eczema

Hypertrophic scar

Rash

Thrombosis

Arrhythmia

Gastrooesophageal reflux disease

Hiatus hernia

Respiratory failure

Decreased appetite

Pneumonia

Oral herpes

Bradyarrhythmia

Supraventricular tachycardia

Vertigo

Cholelithiasis

Hypoglycaemia

Musculoskeletal pain

Osteoarthritis

Neuralgia

Paraesthesia

Parkinson's disease

100%

80%

60%

40%

20%

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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for premature birth include magnesium sulfate and vitamin D. Magnesium sulfate is used for neuroprotection, significantly reducing the risk of cerebral palsy and gross motor dysfunction by stabilizing neuronal membranes and reducing excitotoxicity. Vitamin D is essential for calcium and phosphate metabolism, aiding in the maturation of bones and muscles, which is crucial for the development of premature infants. These treatments are vital as they address the immediate and long-term developmental challenges faced by premature infants, improving their overall health outcomes.

"Stimulation of dihydropyridine-sensitive Ca2+ influx in cultured myoblasts by 1,25(OH)2-vitamin D3".Inhibition of cardiac myocyte maturation by 1,25-dihydroxyvitamin D3.Vitamin D protects against necrotising enterocolitis in newborn mice by activating the ERK signalling pathway.