Clinical trial NCT06896669: Effects of Vitamin D and Calcium on Hyperglycemia and Dyslipidemia in Patients Gestational Diabetes
Official title: Synergistic Effects of Vitamin D and Calcium Supplementation on Hyperglycemia and Dyslipidemia in Patients With Gestational Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Gestational
Keywords: Hyperglycemia
Lipid profiles
Pregnancy outcomes
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2025-03-26
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Fasting plasma glucose (FPG) levels
timeFrame: 6 weeks
measure: HbA1C
timeFrame: 6 weeks
Secondary outcomes:
measure: lipid profile
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Faryal Gohar, MS
role: PRINCIPAL_INVESTIGATOR
References: