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Effect of Suplementation of Vitamin D in Gestational Diabetes Mellitus

Primary Purpose

Vitamin D3, Gestational Diabetes Mellitus in Pregnancy

Status

Completed

Phase

Not Applicable

Locations

Mexico

Study Type

Interventional

Intervention

Vitamin D3

Capsules with placebo (talcum food grade)

About this trial

This is an interventional treatment trial for Vitamin D3

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Eva Elizabet Camarena Pulido

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vitamin D

Placebo

Arm Description

Will receive capsules with 5,000 IU of vitamin D3, one capsule orally once a day for eight weeks

Will receive capsules with placebo (talcum food grade) one capsule orally once a day for eight weeks

Outcomes

Primary Outcome Measures

Changes in the parameters that make up the glycemic profile

Glucose, HBA1c, insuline,

Secondary Outcome Measures

Changes in calcium, phosphorus and vitamin D3

Concentrations of calcium and phosphorus in blood and urine and vitamin D in blood

Full Information

NCT ID

NCT03645109

First Posted

August 22, 2018

Last Updated

March 30, 2021

Sponsor

Eva Elizabet Camarena Pulido

1. Study Identification

Unique Protocol Identification Number

NCT03645109

Brief Title

Effect of Suplementation of Vitamin D in Gestational Diabetes Mellitus

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

February 28, 2020 (Actual)

Primary Completion Date

February 28, 2020 (Actual)

Study Completion Date

March 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Eva Elizabet Camarena Pulido

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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)

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vitamin D3, Gestational Diabetes Mellitus in Pregnancy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Parallel design, two arms

Masking

ParticipantCare Provider

Masking Description

The capsules with vitamin D or placebo have the same organoleptic characteristics. The jars and envelopes that contain them are identical. The envelopes are identified by a code that only knows who will analyze the data

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vitamin D

Arm Type

Experimental

Arm Description

Will receive capsules with 5,000 IU of vitamin D3, one capsule orally once a day for eight weeks

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Will receive capsules with placebo (talcum food grade) one capsule orally once a day for eight weeks

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin D3

Intervention Description

Capsules with 5,000 IU of vitamin D3 once a day (one capsule)

Intervention Type

Other

Intervention Name(s)

Capsules with placebo (talcum food grade)

Intervention Description

Capsules with placebo (talcum food grade)

Primary Outcome Measure Information:

Title

Changes in the parameters that make up the glycemic profile

Description

Glucose, HBA1c, insuline,

Time Frame

Eight weeks

Secondary Outcome Measure Information:

Title

Changes in calcium, phosphorus and vitamin D3

Description

Concentrations of calcium and phosphorus in blood and urine and vitamin D in blood

Time Frame

Eight weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Salvador Mora

Organizational Affiliation

OPD Hospital Civil de Guadalajara

Official's Role

Principal Investigator

Facility Information:

Facility Name

Eva Elizabet Camarena Pulido

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44340

Country

Mexico

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

21706518

Citation

Hollis BW, Johnson D, Hulsey TC, Ebeling M, Wagner CL. Vitamin D supplementation during pregnancy: double-blind, randomized clinical trial of safety and effectiveness. J Bone Miner Res. 2011 Oct;26(10):2341-57. doi: 10.1002/jbmr.463. Erratum In: J Bone Miner Res. 2011 Dec; 26(12):3001.

Results Reference

result

PubMed Identifier

18771564

Citation

Yu CK, Sykes L, Sethi M, Teoh TG, Robinson S. Vitamin D deficiency and supplementation during pregnancy. Clin Endocrinol (Oxf). 2009 May;70(5):685-90. doi: 10.1111/j.1365-2265.2008.03403.x. Epub 2008 Sep 2.

Results Reference

result

PubMed Identifier

24353500

Citation

Parildar H, Dogruk Unal A, Aksan Desteli G, Cigerli O, Guvener Demirag N. Frequency of Vitamin D deficiency in pregnant diabetics at Baskent University Hospital, Istanbul. Pak J Med Sci. 2013 Jan;29(1):15-20. doi: 10.12669/pjms.291.2896.

Results Reference

result

PubMed Identifier

27247730

Citation

Yazdchi R, Gargari BP, Asghari-Jafarabadi M, Sahhaf F. Effects of vitamin D supplementation on metabolic indices and hs-CRP levels in gestational diabetes mellitus patients: a randomized, double-blinded, placebo-controlled clinical trial. Nutr Res Pract. 2016 Jun;10(3):328-35. doi: 10.4162/nrp.2016.10.3.328. Epub 2016 May 16.

Results Reference

result

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Effect of Suplementation of Vitamin D in Gestational Diabetes Mellitus

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