Effect of Suplementation of Vitamin D in Gestational Diabetes Mellitus

Not Applicable

Completed

• Conditions: Vitamin D3; Gestational Diabetes Mellitus in Pregnancy
• Interventions: Other: Capsules with placebo (talcum food grade); Dietary Supplement: Vitamin D3

• Registration Number: NCT03645109
• Lead Sponsor: Eva Elizabet Camarena Pulido

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.

Study Timeline

• Study First Submitted: 2018-08-22
• Study First Submitted QC: 2018-08-23
• Study First Posted: 2018-08-24
• Study Start: 2020-02-28
• Primary Completion: 2020-02-28
• Study Completion: 2020-03-10
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-30
• Last Update Posted: 2021-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Capsules with placebo (talcum food grade)	Will receive capsules with placebo (talcum food grade) one capsule orally once a day for eight weeks
Vitamin D	Vitamin D3	Will receive capsules with 5,000 IU of vitamin D3, one capsule orally once a day for eight weeks

Primary Outcome Measures

Name	Time	Method
Changes in the parameters that make up the glycemic profile	Eight weeks	Glucose, HBA1c, insuline,

Secondary Outcome Measures

Name	Time	Method
Changes in calcium, phosphorus and vitamin D3	Eight weeks	Concentrations of calcium and phosphorus in blood and urine and vitamin D in blood

Trial Locations

Locations (1)

Eva Elizabet Camarena Pulido; 🇲🇽 Guadalajara, Jalisco, Mexico