Effect of Vitamin D3 Supplementation in Pregnancy on Risk of Pre-eclampsia

NCT03101150 | Completed Phase 1 Results DMC

• 1 other identifier: IRB00008644
• Study Type: interventional
• Target: 179
• Locations: 0 countries
• Sites: N/A

Brief Summary

Vitamin D deficient pregnant ladies were selected and randomized into 2 groups for routine daily dose of multivitamin (400IU vitamin D3) versus maximum safest treatment daily dose (4000IU vitamin D3). Participants were assessed and compared for number of pre-eclampsia cases.

Conditions

Vitamin D Deficiency; Pre-Eclampsia

Keywords

Maternal vitamin D; Deficiency; Insufficiency; Pregnancy; Pre-eclampsia; IUGR

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Pre-eclampsia in Both Arms

  Occurrence of pre-eclampsia or not in all patients irrespective of Vitamin D dose.

  From 20 weeks of pregnancy till event of pre-eclampsia seen, whichever came first, assessed up to 32 weeks.

Secondary Outcomes (2)

• Change in Vitamin D Level

  At 36th week of pregnancy

• Number of Patients With Intrauterine Growth Retardation

  At delivery

Study Arms (2)

400 IU Vitamin D3

ACTIVE COMPARATOR

400IU vitamin D3 contained in antenatal multivitamin once daily by mouth starting from 14 weeks of pregnancy till delivery.

Drug: 400 IU Vitamin D3

4000 IU Vitamin D3

EXPERIMENTAL

4000 IU Vitamin D3 drops once daily by mouth starting from 14 weeks of pregnancy till delivery.

Drug: 4000 IU Vitamin D3

Interventions

400 IU Vitamin D3 DRUG

Antenatal multivitamin

Also known as: Materna

400 IU Vitamin D3

4000 IU Vitamin D3 DRUG

4000 IU Vitamin D3 (cholecalciferol) daily = 40 drops daily

Also known as: Vidrop

4000 IU Vitamin D3

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: Pregnant population
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Confirmed singleton pregnancy of less than 13 completed weeks of gestation at the time of consent.
• Planned to receive antenatal care in King Fahad Medical City antenatal clinic.
• The ability to provide written informed consent at the first visit.
• Low risk pregnancy; and Serum vitamin D3 levels less than \< 25nmol/L.

You may not qualify if:

• Mothers with pregnancy with abnormal foetus.
• Previous history of hypertension, pre-eclampsia, recurrent miscarriages.
• Chronic kidney disease, chronic liver disease, and malignancy.

Sponsors & Collaborators

• King Fahad Medical City: lead

MeSH Terms

Conditions

Vitamin D Deficiency; Pre-Eclampsia

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Results Point of Contact

• Title: Consultant Obstetritian and Gynecologist
• Organization: King Fahd Medical City

amali@kfmc.med.sa

00966539417217

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Consultant Obstetric and Gynecology

Study Record Dates

• First Submitted: March 21, 2017
• First Posted: April 4, 2017
• Study Start: October 1, 2012
• Primary Completion: October 31, 2014
• Study Completion: December 31, 2015
• Last Updated: November 2, 2018
• Results First Posted: November 2, 2018

Record last verified: 2018-02