Effect of Suplementation of Vitamin D in Gestational Diabetes Mellitus

March 30, 2021 updated by: Eva Elizabet Camarena Pulido

Effect of Suplementation of 5,000 UI Vitamin D3 on the Glycemic Profile in Patients With Gestational Diabetes Mellitus of the Hospital Civil de Guadalajara Dr. Juan I. Menchaca

Randomized double-blind placebo-controlled clinical trial. Consists of the administration of 5,000 IU of vitamin D3 vs Placebo in patients with gestational diabetes mellitus during eight weeks. The objective is to analyze the effects of the intervention on the biochemical parameters that are part of the glycemic profile (insuline, HBA1c, glucose)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Two groups of patients diagnosed with gestational diabetes mellitus. Once the selection criteria are verified, they will be assigned randomly in one of the two arms,one of them will recive 5,000 IU of vitamin D and the other one placebo (talcum food grade). Baseline measurements of vitamin D, glucose,insulin, HBA1c, calcium, phosphorus. At the end of the eight weeks will be determined again the aforementioned biochemical parameters.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44340
        • Eva Elizabet Camarena Pulido

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria: Patients with a single pregnancy.

  • Patients diagnosed with GDM, which were diagnosed by a glucose tolerance curve 100 grams of glucose, with two altered results from the following: fasting> 95 miligrams / deciliter, 1 hour> 180miligrams / deciliter, 2 hour> 155miligrams / deciliter, 3hous> 140 miligrams / deciliter.
  • Gestational age between 24 -30 weeks confirmed with ultrasound of the 1st or 2nd trimester
  • Age between 18 and 40 years.

Exclusion Criteria: Patients with pre-existing diabetes mellitus

  • Patients with predictive factors for vitamin D hypovitaminosis such as: use of anticonvulsants, renal disease, glomerular filtration rate <60milliliters / minute, thyroid disease or any other pre-existing endocrinological disorders.
  • Hypercalciuria> 300 miligrams / day
  • Patients taking vitamin D supplementation during the 6 months prior to the study (does not include polyvitamins with lower vitamin D concentrations <500 IU)
  • Active and passive smoking patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitamin D
Will receive capsules with 5,000 IU of vitamin D3, one capsule orally once a day for eight weeks
Dietary supplement: Vitamin D3
Capsules with 5,000 IU of vitamin D3 once a day (one capsule)
Placebo Comparator: Placebo
Will receive capsules with placebo (talcum food grade) one capsule orally once a day for eight weeks
Other: Capsules with placebo (talcum food grade)
Capsules with placebo (talcum food grade)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the parameters that make up the glycemic profile
Time Frame: Eight weeks
Glucose, HBA1c, insuline,
Eight weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in calcium, phosphorus and vitamin D3
Time Frame: Eight weeks
Concentrations of calcium and phosphorus in blood and urine and vitamin D in blood
Eight weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eva Elizabet Camarena Pulido

Investigators

  • Principal Investigator: Salvador Mora, OPD Hospital Civil de Guadalajara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2020

Primary Completion (Actual)

February 28, 2020

Study Completion (Actual)

March 10, 2020

Study Registration Dates

First Submitted

August 22, 2018

First Submitted That Met QC Criteria

August 23, 2018

First Posted (Actual)

August 24, 2018

Study Record Updates

Last Update Posted (Actual)

April 2, 2021

Last Update Submitted That Met QC Criteria

March 30, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0240/18HCJIM/18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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