Diabetes Mellitus, Gestational
Conditions
Keywords
Hyperglycemia, Lipid profiles, Pregnancy outcomes
Brief summary
Gestational diabetes mellitus (GDM) is becoming more common globally as a metabolic disease that occurs during pregnancy and influences the mother and the fetus. It has been linked to preeclampsia, C-section, and a higher lifetime risk of developing type 2 diabetes both for mother and the child. Another complication of GDM is dyslipidemia that also accentuates cardiovascular risks, so the care of lipid profiles is essential for the best pregnancy outcomes. The previous literature review indicates that micronutrients including vitamin D and calcium have a bearing on glucose and lipid profiles. Various studies have established that vitamin D improves the insulin response and lipid profile whereas calcium is vital in insulin and glucose homeostasis. Furthermore, it is revealed that calcium induces vitamin D so that it could undergo its full metabolic effect. Hence, the addition of vitamin D and calcium together may enhance glycemic management and lipid profiles of GDM patients. The aim of the present work is to compare the impact of vitamin D and calcium supplementation on lipid profiles and hyperglycemia in GDM patients. It will measure the major metabolic indices fasting plasma glucose, glycated hemoglobin (HbA1c) and lipid profile (LDL, HDL triglycerides) and review the effect of this on pregnancy outcomes. These outcomes will be assessed by a randomized-controlled trial.
Detailed description
A randomized controlled trial study design will be used to assess the efficacy of vitamin D and calcium supplementation in lipid profiles and glycemic index among women with GDM. The sample for the study will consist of 60 pregnant women diagnosed with GDM, aged 18-40 years, and between 24-28 weeks of gestation. Recruitment of participants will be done in antenatal clinics linked to \[Lady Willingdon Hospital Lahore\]. The diagnosis of GDM will be performed according to the results of OGTT following the international criteria. Participants will be randomly divided to one of two groups: * Intervention Group: This group will receive 600 IU of vitamin D3 and 1.5-2 g of calcium daily for 6 weeks. * Control Group: This group will receive a placebo containing no active ingredients. For randomization, a computer-generated sequence will be used to randomly assign participant into the intervention arm or the placebo arm. The study will be conducted as double blind; the participants and the researchers shall not know the group allocations.
Interventions
DIETARY_SUPPLEMENTvitamin D3
600IU of vitamin D3 and 1.5g of calcium will be provided for time period of 6 weeks once daily. In addition, Participants dietary intake will be assessed through 24 hours dietary recall.
Sponsors
Riphah International University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
Participants will get separate treatment protocols and possible efforts will be put to mask the both group about the treatment.
Intervention model description
It will be randomized control trial, in which intervention group will receive 600 IU of vitamin D3 and 1.5-2 g of calcium daily for 6 weeks and control group will receive a placebo containing no active ingredients.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Pregnant women aged 18-40 years. * Gestational age between 24-28 weeks. * Diagnosis of GDM based on OGTT results. * Willingness of participants to provide written informed consent.
Exclusion criteria
* Pre-existing diabetes mellitus (type 1 or type 2). * Chronic kidney or liver disease. * Use of vitamin D or calcium supplements in the last 3 months. * Multiple pregnancies (twins, triplets). * Any major pregnancy complications (e.g., preeclampsia).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fasting plasma glucose (FPG) levels | 6 weeks | fasting plasma glucose measures your blood sugar level post meal after at least 8 hours |
| HbA1C | 6 weeks | HbA1C measure glucose level in past 2 to 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| lipid profile | 6 weeks | Lipid profile, including total cholesterol (TC), low-density lipoprotein (LDL), high-density lipoprotein (HDL), and triglycerides (TG). |
Countries
Pakistan
Contacts
PRINCIPAL_INVESTIGATORFaryal Gohar, MS
Riphah International University
Outcome results
None listed