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

NCT06896669 | Completed DMC

• 1 other identifier: REC/RCR&AHS/24/0848
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Gestational

Keywords

Hyperglycemia; Lipid profiles; Pregnancy outcomes

Outcome Measures

Primary Outcomes (2)

• Fasting plasma glucose (FPG) levels

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

  6 weeks

• HbA1C

  HbA1C measure glucose level in past 2 to 3 months

  6 weeks

Secondary Outcomes (1)

• lipid profile

  6 weeks

Study Arms (2)

Arm and Interventions

OTHER

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

Dietary Supplement: vitamin D3

Arm and placebo

OTHER

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

Dietary Supplement: vitamin D3

Interventions

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.

Also known as: calcium

Arm and Interventions; Arm and placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Gestational diabetes only occurs during pregnancy, which is female specified only .
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Diabetes, Gestational; Hyperglycemia

Interventions

Cholecalciferol; Calcium

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors

Study Officials

• Faryal Gohar, MS

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will get separate treatment protocols and possible efforts will be put to mask the both group about the treatment.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: March 26, 2025
• Study Start: January 28, 2025
• Primary Completion: March 5, 2026
• Study Completion: March 5, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)