Vitamin D Supplementation for the Prevention of GDM

NCT05208827 | Unknown Early Phase 1

• 1 other identifier: GDM20211008
• Study Type: interventional
• Target: 1,600
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Vitamin D; Gestational Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Newborn birth weight

  immediately after delivery

• Gestational age

  immediately after delivery

• Weight gain during pregnancy

  First day after birth

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Control Group

PLACEBO COMPARATOR

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)

Interventions

Vitamin D3 DRUG

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.

Experimental group

The placebo(not contain vitamin D) DRUG

Pills that looked, colored and tasted like vitamin D in the control group, but contained only starch and vegetable oil and no vitamin D.

Control Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: This study only applied to women with normal pregnancies
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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. -

You may not qualify if:

• 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.

Sponsors & Collaborators

• Women's Hospital School Of Medicine Zhejiang University: lead

Study Sites (1)

Women's Hospital School of Medicine Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Danqing Chen, doctor

  Obstetrics and Gynecology Hospital affiliated to Zhejiang University School of Medicine

  STUDY CHAIR

Central Study Contacts

Luyang Han, doctor

CONTACT

18867106248; 524519232@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled study design

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: January 26, 2022
• Study Start: January 1, 2022
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: January 26, 2022

Record last verified: 2022-01

Locations

CN (1)