Hypocalcemia, Pregnancy Complications Affecting Fetus (Diagnosis)
Conditions
Keywords
Hypocalcemia, Feto-maternal outcomes, Oat-based Porridge, Pregnancy nutrition,, Calcium and vit D supplementation, Maternal health
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTOat-Based porridge
participants consumed Oat-based porridge daily as part of their diet during pregnancy alongside standard prenatal supplements
DIETARY_SUPPLEMENTCalcium & Vitamin D3 supplementation
standard prescribed by physicians
Sponsors
University of Lahore Hospital (ULH)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants in the control group (T0) received routine prenatal supplementation prescribed by their physicians, including calcium (1000-1250 mg/day) and vitamin D3 (1000-1200 IU/day). The intervention group (Ta) received the same supplementation regimen plus one daily serving (240 g) of the selected oat-based porridge formulation , providing approximately 400 mg calcium, 590 mg phosphorus, and 175 mg magnesium per serving based on USDA FoodData Central values. Both groups were followed for six months. Participants with severe vitamin D deficiency (serum 25(OH)D \<20 ng/mL) received a loading dose of vitamin D3 (50,000 IU/week for 8 weeks) according to Endocrine Society recommendations, followed by reassessment of serum 25(OH)D levels and maintenance supplementation of 1000-1200 IU/day throughout pregnancy.
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| maternal serum Calcium and Vitamin D concentrations | .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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Fetomaternal Complications | Throughout Pregnancy upto delivery | Number of participants who experience fetomaternal complications including, Delayed fetal growth , Preeclamsia |
Countries
Pakistan
Contacts
PRINCIPAL_INVESTIGATORHABIB UR REHMAN, PhD
NUR International University
Outcome results
None listed