Vitamin D Supplementation for the Prevention of GDM

A Multicenter Randomized Controlled Study of Vitamin D Supplementation in Pregnant Women for the Prevention of Gestational Diabetes

This study was a double-blind multicenter randomized controlled study.

Study Overview

• Status: Recruiting
• Conditions: Gestational Diabetes; Vitamin D
• Intervention / Treatment: Drug: Vitamin D3; Drug: The placebo(not contain vitamin D)

Detailed Description

This study intends to adopt a randomized controlled study design, and randomly divide pregnant women at high risk of GDM into intervention group (VitD3:1600 IU/ day) (n=800) and control group (placebo:2 tablets/day) (n=800) until the end of delivery. The risk of GDM in pregnant women of the two groups was compared, the preventive effect of high-dose VitD supplementation during pregnancy on different subtypes of GDM was determined, and the effects of VitD supplementation on VitD nutritional status during pregnancy and birth outcome and health of offspring were explored, so as to provide evidence-based basis for rational VitD supplementation during pregnancy.

• Study Type: Interventional
• Enrollment (Anticipated): 1600
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Luyang Han, doctor; Phone Number: 18867106248; Email: 524519232@163.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • Women's Hospital School Of Medicine Zhejiang University
      • Contact: Luyang Han, Dr.; Phone Number: +86 18867106248; Email: 524519232@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Pregnant women who are 8 to 14 weeks pregnant ; ② 18 to 45 years old; ③ Pregnant women at high risk of GDM (meeting any of the following conditions) : A) BMI ≥24 kg/m2 before or during pregnancy; B) family history of diabetes or GDM; C) Previous pregnancy diagnosed as GDM; D) with a history of macrosomia (≥4000 g); E) A history of abnormal glucose tolerance: 5.7-6.4% hBA1c or 6.1-7.0 mmol/L fasting blood glucose.

  • Sign informed consent. -

Exclusion Criteria:

• Patients with a history of diabetes or currently diagnosed diabetes (including type 1 and type 2 diabetes);

  • HBA1c ≥6.5% or fasting blood glucose & GT;7.0 mmol/L with obvious symptoms of diabetes;

    • Patients with current or past abnormalities in calcium metabolism (hypoparathyroidism/hyperthyroidism, kidney stones), high urinary calcium or hypercalcemia;

      • Daily VitD intake & GT;800 IU. ⑤ Suffering from serious chronic diseases (heart, lung, liver, kidney and other dysfunction) or mental illness;

        • They cannot walk 100 meters safely; 7. Multiple pregnancies or assisted reproduction; ⑧ need complex diet;

          • Cannot speak Mandarin fluently; ⑩ Those who are participating in other clinical trials or who are considered unsuitable for clinical trials by researchers for other reasons.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Take two tablets once a day.Each tablet contains 800 units of vitamin D3, for a total of 1600 units taken orally daily	Drug: Vitamin D3; Participants began to take medication at 12 weeks of gestation, and participants in the second trimester began to take medication at the time point of enrollment.The dosage is 2 tablets per day, taken orally for 12 weeks.The drug in the intervention group was fat-soluble vitamin D3, which was produced by Sinopril Holding Starfish Pharmaceutical (Xiamen) Co., LTD. Each tablet contained 800 units of vitamin D3, vegetable oil and starch as auxiliary material.
Placebo Comparator: Control Group; The control group received the same packaged, similar-looking, similar-tasting placebo from the same manufacturer, containing starch, peanut oil (no pharmaceutical value)	Drug: The placebo(not contain vitamin D); Pills that looked, colored and tasted like vitamin D in the control group, but contained only starch and vegetable oil and no vitamin D.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gestational diabetes	We will judge whether patients have gestational diabetes based on OGTT results (fasting, 1-hour, 2-hour blood glucose results) .	At 24-28 weeks of gestation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Newborn birth weight	Weight of newborn at birth	immediately after delivery
Gestational age	Determine the gestational age of the woman and whether preterm birth exists	immediately after delivery
Weight gain during pregnancy	Weigh the pregnant woman on the first day after delivery and subtract her weight before pregnancy from the birth examination book	First day after birth

Collaborators and Investigators

• Sponsor: Women's Hospital School Of Medicine Zhejiang University
• Investigators: Study Chair: Danqing Chen, doctor, Obstetrics and Gynecology Hospital Affiliated to Zhejiang University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Anticipated): January 1, 2025
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: November 24, 2021
• First Submitted That Met QC Criteria: January 11, 2022
• First Posted (Actual): January 26, 2022

Study Record Updates

• Last Update Posted (Actual): January 26, 2022
• Last Update Submitted That Met QC Criteria: January 11, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Pregnancy Complications; Diabetes, Gestational; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Vitamins; Ergocalciferols
• Other Study ID Numbers: GDM20211008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No