Effect of Suplementation of Vitamin D in Gestational Diabetes Mellitus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-28

Study Completion Date

2020-03-10

Brief Summary

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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)

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Detailed Description

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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.

Conditions

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Vitamin D3 Gestational Diabetes Mellitus in Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel design, two arms

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

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

Study Groups

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Vitamin D

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

Group Type EXPERIMENTAL

Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Capsules with placebo (talcum food grade)

Intervention Type OTHER

Capsules with placebo (talcum food grade)

Interventions

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Vitamin D3

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

Intervention Type DIETARY_SUPPLEMENT

Capsules with placebo (talcum food grade)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No