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

NCT ID: NCT06896669

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-28
• Study Completion Date: 2025-12-31

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.

Conditions

Diabetes Mellitus, Gestational

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Arm and Interventions

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.

Group Type: OTHER

vitamin D3

Intervention Type: DIETARY_SUPPLEMENT

600IU of vitamin D3 and 1.5 to 2g 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.

Arm and placebo

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

Group Type: OTHER

vitamin D3

Intervention Type: DIETARY_SUPPLEMENT

600IU of vitamin D3 and 1.5 to 2g 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.

Interventions

vitamin D3

600IU of vitamin D3 and 1.5 to 2g 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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

calcium

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Faryal Gohar, MS

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Riphah International University

Lahore, Punjab Province, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

IMRAN AMJAD, PhD

Role: CONTACT

Imran.amjad@riphah.edu.pk

9233224390125

Muhammed Imran Hussain, PhD

Role: CONTACT

imran.hussain@riphah.edu.pk

+923004478597

Facility Contacts

Imran Amjad, PhD

Role: primary

Imran.amjad@riphah.edu.pk

9233224390125

Muhmmad Asif javed, MS

Role: backup

a.javed@riphah.edu.pk

03224209422

Other Identifiers

REC/RCR&AHS/24/0848

Identifier Type: -

Identifier Source: org_study_id