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Fetal Growth RetardationPhase 1NCT06565728

Vitamin D Versus Sildenafil Citrate in Fetal Growth Restriction

A Phase 1 study testing Vitamin D3 2000 UNT Oral Tablet in people with Fetal Growth Retardation, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Fetal growth restriction, also named Intrauterine growth restriction is a prevalent disease in pregnancy , it is a descriptive term for a pathological process, and can be described as the process where a fetus who has a certain growth potential based on genetic criteria is limited in its growth because of a… Read more about this study

Who is it for?
Ages 20 to 40 years, women only
Conditions the study is for
Fetal Growth Retardation
What is being tested?
Vitamin D3 2000 UNT Oral Tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
99 participants
Where
1 siteEgypt
Study dates
3 Nov 2022to 6 May 2023
Phase
Phase 1
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 20 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Women with singleton spontaneous pregnancy with fetal growth restriction more than 28 weeks, confirmed by ultrasound based on estimated fetal weight and measurement of abdominal circumference (AC)< 10th percentile for gestational age or lag of two weeks or more between the current measurements and expected one, dating since the first trimester of pregnancy.
  • Age 20- 40 years.
  • Patients with regular menstrual pattern before pregnancy.
  • Patients are able to attend follow up as planned.

Who cannot join

  • Patients with uncertain gestational age
  • Maternal cardiovascular disease (congenital, ischemic and rheumatic heart diseases), diabetes, kidney disease, hepatic disease, anemia, antepartum hemorrhage and placenta previa.
  • Patients with known or suspected foetal anomalies
  • Fetal growth restriction because of severe preeclampsia.
  • Use of vasodilator medication.
  • Multiple pregnancies
  • Smoking, drugs or alcohol abusers.
  • Obstetric complications (intrauterine infection, bleeding, premature rupture of membranes).

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • kasr Alainy University Hospital

    Cairo, 11312

Other trials in Egypt

About this study

Official title: Comparative Study of the Role of Vitamin D Supplementation, Versus Sildenafil Citrate in Patients Diagnosed With Fetal Growth Restriction, Randomized Control Trial

Fetal growth restriction, also named Intrauterine growth restriction is a prevalent disease in pregnancy , it is a descriptive term for a pathological process, and can be described as the process where a fetus who has a certain growth potential based on genetic criteria is limited in its growth because of a pathological environmental influence

Read the detailed description

Fetal or Intrauterine growth restriction, describes a pathological condition in which the fetus fails to grow to its biological potential, because of poor placental function , both American society of obstetrics and gynecology of and Royal college of obstetrics and gynecology have adopted the definition of Intrauterine growth restriction as estimated fetal weight is less than 10th percentile .

It is a multifaceted problem that increases the risk of hypoxemia, acidemia, preterm deaths, and maternal distress, and disposes the infant to a number of metabolic disorders, polycythemia, lung problems, intraventricular hemorrhage, cognitive dysfunction, and cerebral palsy, which occur in both term and preterm infants .

Vitamin D deficiency is highly prevalent among pregnant women, not only vitamin D deficiency during pregnancy causes maternal and fetal side effects, it also increases the risk of preeclampsia, gestational diabetes, preterm birth, and birth of a child younger than small for gestational age, inadequate fetal immune system, wheezing and eczema, and risk of respiratory infections in the infants.

Vitamin D is a transcriptional regulator of endothelial NO synthase, effectively increasing the production of NO, the most potent vasodilator within the vasculature. previous Studies showed that the vitamin-D receptors play a critical role in maintaining vascular health, and this assumption was supported by data Showing reduced NO production.

It was suggested that vitamin D improves vascular function via reducing the production of NO-scavenging oxygen radicals and subsequently improving NO bioavailability and maintain vascular health.

Vitamin D level during the pregnancy in women with low-birth-weight infants was significantly lower than its level in other women. It was eventually found that vitamin D level in pregnancy was effective in bone metabolism and growth process of the fetus .

Vitamin D deficiency during pregnancy causes potentially harmful implications in the mother and the fetus. Several studies have referred to the relationship between vitamin D deficiency and the incidence of intrauterine growth retardation.

Some studies have shown that increasing the amount of 25-hydroxy vitamin D in the bloodstream before and during pregnancy contributes to nesting and causes stability in pregnancy, as well as increased calcium uptake required for fetal growth and development.

Studies have also indicated that the decreased expression of vitamin D receptors results in functional impairment and limitation in the beneficial effects of vitamin D in regulating the fetus-placental growth.

Maternal vitamin D deficiency was observed in all pathological pregnancies with a decrease in the staining levels of placental vitamin D receptor in intrauterine growth retardation. And severe vitamin D deficiency may play an important role in placental inflammation, which in turn may lead to a higher risk of intrauterine growth retardation and other neonatal side effects.

Vitamin D supplementation doses should be: 1500-2000 IU/day, necessary for maintaining 25(OH)D serum level above 30 ng/mL, currently available studies seem to recommend starting prophylaxis with vitamin D at the beginning of the pregnancy, to be continued throughout the entire pregnancy and during lactation.

The standard options for management of intrauterine growth retardation are expectant management till pregnancy termination. This involves modification of maternal lifestyle together with fetal surveillance, since impaired placental circulation is a major cause, vasodilators may have their role .

Sildenafil citrate (trade name: Revatio, Viagra, Respatio, etc.) was emerged as a drug helping vasodilation which may represent an effective intervention for intrauterine growth retardation pregnancies with dose of 20 mg once daily. Studies showed that mean birth weight at delivery was increased significantly with sildenafil usage. Of course, this had its value in decreasing admission to the newborn nursery unit.

Sildenafil citrate treatment may present a new hope towards better perinatal outcomes for pregnancies complicated by intrauterine growth retardation that may help to decrease neonatal admission to newborn nursery.

Sildenafil citrate induces vasodilation through inhibition of type 5 phosphodiesterase (PDE5) which is responsible for the degradation of cGMP to guanosine monophosphate. Therefore, inhibiting PDE5 delays the breakdown of cGMP and increases vasodilation.

Being tested
Vitamin D3 2000 UNT Oral Tablet
Medical subject headings
Fetal Growth Retardation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitamin D3 2000 UNT Oral TabletDrug

    Also called Sildenafil Citrate, Asprin

    To assess the role of vitamin D3, versus sildenafil citrate, versus control group in pregnancies complicated by fetal growth restriction

Study groups in NCT06565728
Study groupRoleWhat they receive
Group A: Vitamin D3 groupActive comparatorConsists of 33 pregnant women who received oral vitamin D3 (vitamin D-3 2000 IU) and low dose aspirin.
Receives: Drug: Vitamin D3 2000 UNT Oral Tablet
Group A: Sildenafil groupActive comparatorConsists of 33 pregnant women who received oral sildenafil citrate 20 mg (Respatio) and low dose aspirin
Receives: Drug: Vitamin D3 2000 UNT Oral Tablet
Group A: Control groupActive comparatorConsists of 33 pregnant women who received low dose aspirin only
Receives: Drug: Vitamin D3 2000 UNT Oral Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gestational age Measurements

    Estimation of The Gestational age at the week 28 of gestation by measuring fetal head circumference, Abdominal Circumference and fetal femur length.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2024
  2. Study start3 Nov 2022
  3. Primary completion1 May 2023
  4. Study completion6 May 2023

Resources

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
99 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06565728
Sponsor's protocol ID
Fetal Growth Restriction
Status last verified
Nov 2022
First submitted
14 Jul 2024
Last updated
22 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Vitamin D3 2000 UNT Oral Tablet in people with Fetal Growth Retardation, run by Cairo University at 1 site in Egypt.

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 4 inclusion and 8 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 22 Aug 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 Egypt. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Gestational age Measurements (time frame: 6 months). 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 22 Aug 2024.

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