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Effect of Suplementation of Vitamin D in Gestational Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03645109
Recruitment Status : Not yet recruiting
First Posted : August 24, 2018
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
Eva Elizabet Camarena Pulido, Hospital Civil Juan I. Menchaca

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)

Condition or disease Intervention/treatment Phase
Vitamin D3 Gestational Diabetes Mellitus in Pregnancy Dietary Supplement: Vitamin D3 Other: Capsules with placebo (talcum food grade) Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel design, two arms
Masking: Double (Participant, Care 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
Primary Purpose: Treatment
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
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : September 29, 2019
Estimated Study Completion Date : December 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

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)




Primary Outcome Measures :
  1. Changes in the parameters that make up the glycemic profile [ Time Frame: Eight weeks ]
    Glucose, HBA1c, insuline,


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03645109


Contacts
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Contact: Eva Camarena, PhMd +5239424400 ext 52324 eecamarena@hcg.gob.mx
Contact: Jorge Gonzalez, PhMd +5239424400 ext 52324 glezmo@hotmail.com

Sponsors and Collaborators
Eva Elizabet Camarena Pulido
Investigators
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Principal Investigator: Salvador Mora OPD Hospital Civil de Guadalajara

Publications of Results:
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Responsible Party: Eva Elizabet Camarena Pulido, Clinical professor, Hospital Civil Juan I. Menchaca
ClinicalTrials.gov Identifier: NCT03645109    
Other Study ID Numbers: 0240/18HCJIM/18
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes, Gestational
Pregnancy in Diabetics
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents