Vitamin D deficiency
Conditions
Interventions
They will be defined as the study groups:
• • Group 1 (G1) - pregnant women with DMG without vitamin D deficiency will not receive supplementation. N = 40
• Group 2 (G2) - pregnant women with DMG and
deficient <10 ng / mL.
Dietary supplement
SP6.051.227
Sponsors
Universidade Federal do Rio de Janeiro
Maternidade Escola da Universidade Federal do Rio de Janeiro
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: The criteria for selection of pregnant women in the groups will be: adults (chronological age> 20 years at conception), diagnosis of Gestational Diabetes Mellitus with gestational age <28 weeks, single fetus gestation, nonsmokers.
Exclusion criteria
Exclusion criteria: As exclusion criteria: pregnant women with other chronic diseases, such as renal or hepatic disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adequacy of vitamin D levels in the form of 25-OHD will be categorized as> 30ng / ml, insufficient 21-30 ng / mL; deficient <10 ng / mL.The adequacy of vitamin D levels is expected to increase around 50% with supplementation.Data collected at baseline (averaged one week prior to study) and study endpoint after 8 weeks of supplementation. | — |
Secondary
| Measure | Time frame |
|---|---|
| The birth conditions to be evaluated are birth weight (g); gestational age at birth (weeks), according to date of last menstruation (DUM) and ultrasonography; presence of early neonatal complications; congenital malformations; weight index (calculated on the basis of birth weight and length - kg / m3); length (cm); Apgar score at 1st and 5th minutes; gestational age / weight correlation at birth, according to Intergrowth (2014) and; type of delivery (normal, forceps, surgical - cesarean section). Data on weight, length and gestational age will be recorded continuously, and subsequently categorized according to WHO recommendations (2006, 2014). ;Presentation of the outcomes: glycemic control; evaluation of gestational weight gain and the presence of maternal and neonatal intercurrences during pregnancy. Method of evaluation of glycemic control: - Glycemic control of DM per trimester of gestation - good control (fasting glycemia of less than 95mg / dL and postprandial of 1 hour less than 140mg / dL), and lack of control (episodes of hypoglycemia - glycemia 95mg / dl and or 1h after meal> 140mg / dl). - Method of assessing the adequacy of total gestational weight: This variable will be categorized as gain below, adequate and above recommendation and; of dichotomous form in adequate and inadequate (IOM, 2009). - Method of evaluation of gestational intercurrences, in childbirth / puerperium: Interventions will be considered: Hypertensive syndrome in SHG pregnancy, urinary tract infection, premature amniorrexis, polydramnia / oligodramnia, anemia, gestational night blindness and others according to the reference for diagnosis of prenatal care regulations (2013; 2014). This variable will be dichotomously categorized in the presence or absence of intercurrences. SHG will also be analyzed separately, considering the stages - gestational hypertension, preeclampsia, eclampsia, HELLP (MS, 2013, 2014). | — |
Countries
Brazil
Contacts
Public ContactPatricia Padilha
Universidade Federal do Rio de Janeiro
Outcome results
None listed