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

University of Lahore Hospital (ULH)192 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

192

Conditions

Hypocalcemia

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 40 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

maternal serum Calcium and Vitamin D concentrations

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.

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 .

Secondary Outcomes

Incidence of Fetomaternal Complications

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

Time frame: Throughout Pregnancy upto delivery