NCT06139133

Brief Summary

A clinical trial will be conducted in Chemical pathology department in collaboration with Gyne \&Obs department of PRH, IIMC over a period of 02 years w.e.f. December 15, 2023. 350 pregnant women with 07-11 weeks of gestation and having a high risk for GDM with low Vitamin D3 levels and normal response to 75g OGTT will be randomly assigned to receive either vitamin D3 supplementation (2 00,000 IU/Week) for 04 -06 weeks or Placebo. These women will be checked for the diagnosis of GDM with 75 g OGTT at 24- 28 weeks of gestation. The outcome of the study will be the incidence of GDM based on the International Association of Diabetes and Pregnancy Study Groups Criteria.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

1.9 years

First QC Date

November 14, 2023

Last Update Submit

November 23, 2023

Conditions

Gestational Diabetes Mellitus

Keywords

Gestational Diabetes MellitusPregnancyHigh risk womenVitamin D supplementation

Outcome Measures

Primary Outcomes (1)

  • Gestational diabetes mellitus with 75g OGTT

    75g-OGTT is an oral glucose tolerance test done by ingesting 75 g glucose dissolved in water in the morning at 7- 8 am. * Patient seated quietly \& relaxed for 30 mins before taking the test * A zero-time (baseline) blood sample is drawn * The patient is then given a 75-g glucose solution to drink within 5 minutes * 2nd Sample - 1h after consumption of sugar to measure the blood glucose * 3rd Sample- 2h after consumption of sugar to measure blood glucose * Both blood samples should be kept in fluoride-containing collection tubes Interpretation of Test: GDM diagnosed if any one of the following is present after 75g OGTT: * FPG: \>92 mg/dl * 1-hour PG: \>180 mg/dl * 2-hour PG: \>153 mg/dl * THE WHO GUIDELINES (2018)

    28 weeks

Study Arms (2)

Placebo supplementation Group

PLACEBO COMPARATOR

Pregnant women with 07-11 weeks of gestation having normal response to 75g OGTT but with low levels of Vitamin D3 (\<30ng/ml) will be included. The study subjects will be randomly assigned to receive placebo until delivery.

Drug: Placebo supplementation

Vitamin D supplementation group

EXPERIMENTAL

pregnant women with 07-11 weeks of gestation having normal response to 75g OGTT but with low levels of Vitamin D3 (\<30ng/ml) will be included for Vitamin D3 supplementation (2 00,000 IU/Week) for 04 -06 week. The study subjects will be randomly assigned to receive vitamin D3 supplementation (2 00,000 IU/Week) for 04 -06 weeks.

Drug: Vitamin D supplementation

Interventions

Placebo supplementationDRUG

Placebo

Placebo supplementation Group
Vitamin D supplementationDRUG

Vitamin D3 supplementation (2 00,000 IU/Week)

Vitamin D supplementation group

Eligibility Criteria

Age21 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women with 07-11 weeks of gestation
  • Years age range
  • Pregnant women with high risk for GDM
  • history of GDM in their previous pregnancy,
  • one or more first-degree relative diagnosed with diabetes mellitus,
  • overweight-BMI \>25 kg/m2 or obese-BMI \>30 kg/m2 at their first antenatal visit
  • with a history of polycystic ovarian syndrome.
  • Pregnant women with 07-11 weeks of gestation having normal response to 75g OGTT
  • Low levels of Vitamin D3 (\<30ng/ml)

You may not qualify if:

  • Women already diagnosed with diabetes mellitus
  • Any other systemic disease.
  • High risk pregnant women diagnosed with diabetes on the basis of 75g OGTT
  • High risk pregnant women with normal vitamin D3 levels (\>30ng/ml).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pakistan Railway Hospital

Rawalpindi, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Muhammad Nadim Akbar Khan, FCPS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Nadim Akbar Khan, FCPS

CONTACT

+923005190704nadeem.akbar@riphah.edu.pk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: RCT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2023

First Posted

November 18, 2023

Study Start

January 1, 2024

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

November 29, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)