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)
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
Capsules with 5,000 IU of vitamin D3 once a day (one capsule)
Capsules with placebo (talcum food grade)
Eva Elizabet Camarena Pulido
Guadalajara, Jalisco, Mexico
Changes in the parameters that make up the glycemic profile
Glucose, HBA1c, insuline,
Time frame: Eight weeks
Changes in calcium, phosphorus and vitamin D3
Concentrations of calcium and phosphorus in blood and urine and vitamin D in blood
Time frame: Eight weeks
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