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

NCT07751198 | Completed

• 1 other identifier: 518/24
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypocalcemia; Pregnancy Complications Affecting Fetus (Diagnosis)

Keywords

Hypocalcemia; Feto-maternal outcomes; Oat-based Porridge; Pregnancy nutrition,; Calcium and vit D supplementation; Maternal health

Outcome Measures

Primary Outcomes (1)

• 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.

  .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 (1)

• Incidence of Fetomaternal Complications

  Throughout Pregnancy upto delivery

Study Arms (2)

CONTROL GROUP

ACTIVE COMPARATOR

Participants receiving standard supplementation of calcium and vit.D

Dietary Supplement: Calcium & Vitamin D3 supplementation

EXPERIMENTAL GROUP

EXPERIMENTAL

Participants receiving standard supplementation of calcium and vit.D along with interventional Oat-Based Porridge

Dietary Supplement: Oat-Based porridge; Dietary Supplement: Calcium & Vitamin D3 supplementation

Interventions

Oat-Based porridge DIETARY_SUPPLEMENT

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

EXPERIMENTAL GROUP

Calcium & Vitamin D3 supplementation DIETARY_SUPPLEMENT

standard prescribed by physicians

Also known as: prenatal dietary supplement

CONTROL GROUP; EXPERIMENTAL GROUP

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Lahore Hospital (ULH): lead

Study Sites (1)

Saira Memorial Hospital Model Town Lahore Pakistan

Lahore, Punjab Province, 54700, Pakistan

Location

Related Publications (1)

• Arshad, M. F., Elamin, A., Bennet, W., Choudhari, Y. K., & Balasubramanian, S. P. (2023). Abnormal Calcium Levels are Associated With Worse Maternal and Fetal Outcomes; Results From an Exploratory Study. The Journal of Clinical Endocrinology & Metabolism, 108(12), e1642-e1648. Association, W. M. (2013). World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. Jama, 310(20), 2191-2194. Bako, B., El-Nafaty, A., Mshelia, D., Gali, R., Isa, B., & Dungus, M. (2021). Prevalence and risk factors of hypocalcemia among pregnant and non-pregnant women in Maiduguri, Nigeria: A cross-sectional study. Nigerian Journal of Clinical Practice, 24(1), 75-80. Binou, P., Yanni, A. E., & Karathanos, V. T. (2022). Physical properties, sensory acceptance, postprandial glycemic response, and satiety of cereal based foods enriched with legume flours: A review. Critical reviews in food science and nutrition, 62(10), 2722-2740. Chimonyo, V. G. P., Govender, L., Nyathi, M., Scheelbeek, P. F. D., Choruma, D. J., Mustafa, M., . . . Mabhaudhi, T. (2023). Can cereal-legume intercrop systems contribute to household nutrition in semi-arid environments: A systematic review and meta-analysis. Frontiers in nutrition, 10, 1060246. Ding, J.-J., Chiu, C.-F., Su, Y.-T., Lin, S.-H., Chiang, M.-C., Chu, S.-M., . . . Tseng, M.-H. (2025). Neonatal hypocalcemia caused by maternal hypercalcemia: clinical characteristics, etiology, treatment, and outcome. Pediatric Research, 1-9. Forsido, S. F., Duguma, H. T., Lema, T. B., Sturm, B., & Hensel, O. (2019). Nutritional and sensory quality of composite extruded complementary food. Food Science & Nutrition, 7(2), 882-889. Hofmeyr, G. J., Lawrie, T. A., Atallah, Á. N., & Torloni, M. R. (2018). Calcium supplementation during pregnancy for preventing hypertensive disorders and related problems. Cochrane database of systematic reviews(10).

  BACKGROUND

MeSH Terms

Conditions

Hypocalcemia; Disease

Interventions

Calcium

Condition Hierarchy (Ancestors)

Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Water-Electrolyte Imbalance; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors

Study Officials

• HABIB UR REHMAN, PhD

  NUR International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 25, 2026
• First Posted: August 7, 2026
• Study Start: August 1, 2024
• Primary Completion: January 20, 2025
• Study Completion: February 14, 2025
• Last Updated: August 7, 2026

Record last verified: 2026-08

Locations

PA (1)