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NCT Number: NCT03645109

Effect of Suplementation of Vitamin D in Gestational Diabetes Mellitus

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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Key information

Conditions

Vitamin D3 Gestational Diabetes Mellitus in Pregnancy

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Eva Elizabet Camarena Pulido

Guadalajara, Jalisco, 44340, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitamin D3

Dietary Supplement

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

Capsules with placebo (talcum food grade)

Other

Capsules with placebo (talcum food grade)

Primary outcomes

  1. Changes in the parameters that make up the glycemic profile

    Time frame: Eight weeks

    Glucose, HBA1c, insuline,

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Eva Elizabet Camarena Pulido

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 24, 2018
Registry last updated
Apr 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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