Effect of Suplementation of Vitamin D in Gestational Diabetes Mellitus

NCT03645109 | Completed

• 1 other identifier: 0240/18HCJIM/18
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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)

Conditions

Vitamin D3; Gestational Diabetes Mellitus in Pregnancy

Outcome Measures

Primary Outcomes (1)

• Changes in the parameters that make up the glycemic profile

  Glucose, HBA1c, insuline,

  Eight weeks

Secondary Outcomes (1)

• Changes in calcium, phosphorus and vitamin D3

  Eight weeks

Study Arms (2)

Vitamin D

EXPERIMENTAL

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

Dietary Supplement: Vitamin D3

Placebo

PLACEBO COMPARATOR

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

Other: Capsules with placebo (talcum food grade)

Interventions

Vitamin D3 DIETARY_SUPPLEMENT

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

Vitamin D

Capsules with placebo (talcum food grade) OTHER

Capsules with placebo (talcum food grade)

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eva Elizabet Camarena Pulido: lead

Study Sites (1)

Eva Elizabet Camarena Pulido

Guadalajara, Jalisco, 44340, Mexico

Location

Related Publications (4)

• Hollis BW, Johnson D, Hulsey TC, Ebeling M, Wagner CL. Vitamin D supplementation during pregnancy: double-blind, randomized clinical trial of safety and effectiveness. J Bone Miner Res. 2011 Oct;26(10):2341-57. doi: 10.1002/jbmr.463. Erratum In: J Bone Miner Res. 2011 Dec; 26(12):3001.

  PMID: 21706518 RESULT

• Yu CK, Sykes L, Sethi M, Teoh TG, Robinson S. Vitamin D deficiency and supplementation during pregnancy. Clin Endocrinol (Oxf). 2009 May;70(5):685-90. doi: 10.1111/j.1365-2265.2008.03403.x. Epub 2008 Sep 2.

  PMID: 18771564 RESULT

• Parildar H, Dogruk Unal A, Aksan Desteli G, Cigerli O, Guvener Demirag N. Frequency of Vitamin D deficiency in pregnant diabetics at Baskent University Hospital, Istanbul. Pak J Med Sci. 2013 Jan;29(1):15-20. doi: 10.12669/pjms.291.2896.

  PMID: 24353500 RESULT

• Yazdchi R, Gargari BP, Asghari-Jafarabadi M, Sahhaf F. Effects of vitamin D supplementation on metabolic indices and hs-CRP levels in gestational diabetes mellitus patients: a randomized, double-blinded, placebo-controlled clinical trial. Nutr Res Pract. 2016 Jun;10(3):328-35. doi: 10.4162/nrp.2016.10.3.328. Epub 2016 May 16.

  PMID: 27247730 RESULT

MeSH Terms

Interventions

Cholecalciferol

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Salvador Mora

  OPD Hospital Civil de Guadalajara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical professor

Model Details: Parallel design, two arms

Study Record Dates

• First Submitted: August 22, 2018
• First Posted: August 24, 2018
• Study Start: February 28, 2020
• Primary Completion: February 28, 2020
• Study Completion: March 10, 2020
• Last Updated: April 2, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)