Effects of Vitamin D and Calcium on Hyperglycemia and Dyslipidemia in Patients Gestational Diabetes

Riphah International University

Status

Enrolling

Conditions

Diabetes Mellitus, Gestational

Treatments

Dietary Supplement: vitamin D3

Study type

Interventional

Funder types

Other

Identifiers

NCT06896669

REC/RCR&AHS/24/0848

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

Arm and Interventions

Other group

Description:

Experimental: Vitamin D3 and calcium This group will be receive vitamin D3 600 IU and 1.5-2 g of calcium. This treatment will be conducted for 6 week per day after meal.

Treatment:

Dietary Supplement: vitamin D3

Arm and placebo

Other group

Description:

: This group will receive a placebo containing no active ingredients and it will conducted for 6 weeks per day.

Treatment:

Dietary Supplement: vitamin D3