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NCT Number: NCT06896669

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

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.

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Key information

Conditions

Diabetes Mellitus, Gestational Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Riphah International University

Lahore, Punjab Province, 54000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Vitamin D3

Dietary Supplement

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.

Other names: calcium

Primary outcomes

  1. Fasting plasma glucose (FPG) levels

    Time frame: 6 weeks

    fasting plasma glucose measures your blood sugar level post meal after at least 8 hours

  2. HbA1C

    Time frame: 6 weeks

    HbA1C measure glucose level in past 2 to 3 months

Secondary outcomes

  1. lipid profile

    Time frame: 6 weeks

    Lipid profile, including total cholesterol (TC), low-density lipoprotein (LDL), high-density lipoprotein (HDL), and triglycerides (TG).

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 26, 2025
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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