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Completed

NCT Number: NCT07751198

Therapeutic Effects of Oat-based Porridge on Fetomaternal Outcomes Among Hypocalcemic Antenatal Women

This study evaluates the therapeutic effects of an oat-based porridge composite on fetomaternal outcomes and calcium/ vitamin D status among hypocalcemic antenatal women. Pregnant women diagnosed with hypocalcemia are evaluated to determine the efficacy of composite cereal supplementation alongside standard medical care. Blood samples collected at the 8th and 33rd weeks of gestation are analyzed to assess changes in serum calcium and Vitamin D concentrations. The study aims to evaluate whether oat-based porridge supplementation provides beneficial nutritional support for managing hypocalcemia during pregnancy.

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Saira Memorial Hospital Model Town Lahore Pakistan

Lahore, Punjab Province, 54700, Pakistan

About this study

Pregnant women diagnosed with hypocalcemia are enrolled and allocated into two primary study groups: a control group (T0) receiving standard clinical care (calcium and Vitamin D supplementation as prescribed by attending physicians) and an interventional group(Ta) receiving an optimized oat-based composite porridge formulation in combination with standard supplementation.

The composite oat-based porridge formulations (composed of oats, chickpeas, almonds, chia seeds, and sorghum) are designed to improve maternal mineral adequacy. Maternal blood samples are drawn at baseline (8th week of gestation) and follow-up (33rd week of gestation) to measure changes in serum calcium (mg/dL) and Vitamin D (ng/mL) concentrations, as well as to assess related fetomaternal health parameters from baseline to delivery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Already taking vitamin D and calcium supplements as prescribed by the doctor.
  • Pregnant women in their 2nd and 3rd trimester.
  • Women between 20 to 40 years of age will be included.
  • Women with mild to moderate hypocalcemia (serum calcium less than 8-8.6 mg/dl) and 25(OH)D less than 30ng/ml will be entered to study.

Exclusion criteria

  • Women having twin pregnancy.
  • Gestational diabetes or diabetes before pregnancy.
  • Chronic hypertension.
  • Fetal anomaly, oligohydramnios or polyhydramnios, parathyroid disorders, hepatic or renal diseases, malnutrition.
  • Use of anti-convulsive and immunosuppressive drugs.

Treatment and study plan

Oat-Based porridge

Dietary Supplement

participants consumed Oat-based porridge daily as part of their diet during pregnancy alongside standard prenatal supplements

Calcium & Vitamin D3 supplementation

Dietary Supplement

standard prescribed by physicians

Other names: prenatal dietary supplement

Primary outcomes

  1. maternal serum Calcium and Vitamin D concentrations

    Time frame: .Blood samples were collected at the 8th and 33rd weeks of gestation to assess changes in plasma calcium concentration through blood sampling, from enrollment to delivery .

    Evaluating using maternal blood samples to measure change in serum calcium levels in mg/dL And Vitamin D Levels in ng/mL from baseline to delivery.

Secondary outcomes

  1. Incidence of Fetomaternal Complications

    Time frame: Throughout Pregnancy upto delivery

    Number of participants who experience fetomaternal complications including, Delayed fetal growth , Preeclamsia

Sponsors and collaborators

Lead sponsor

University of Lahore Hospital (ULH)

Network

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 7, 2026
Registry last updated
Aug 7, 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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