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CompletedNCT07751198Updated Aug 12, 2026

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

An interventional study of Oat-Based porridge and Calcium & Vitamin D3 supplementation in Hypocalcemia and Pregnancy Complications Affecting Fetus (Diagnosis), sponsored by University of Lahore Hospital (ULH). Completed at 1 site in Pakistan. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-08-12.

Sponsored by University of Lahore Hospital (ULH) · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 11 months after the study started (first participant enrolled Aug 2024, registered Jul 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
192
Allocation
Non-randomized
Ages
20 Years to 40 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Hypocalcemia
  • Pregnancy Complications Affecting Fetus (Diagnosis)

Keywords

  • Hypocalcemia
  • Feto-maternal outcomes
  • Oat-based Porridge
  • Pregnancy nutrition,
  • Calcium and vit D supplementation
  • Maternal health
03

In context

Hypocalcemia

98 studies on the registry are indexed under Hypocalcemia; 16 are open to participants now.

This study's enrollment of 192 is above the median of 84 across 66 interventional studies indexed under Hypocalcemia.

Browse Hypocalcemia studies →

Lead sponsor

University of Lahore Hospital (ULH) is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 drugs.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
192 participants (actual)

Study arms

  • Active comparator
    CONTROL GROUP

    Participants receiving standard supplementation of calcium and vit.D

    Dietary Supplement: Calcium & Vitamin D3 supplementation

  • Experimental
    EXPERIMENTAL GROUP

    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

  • 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

    Also known as: prenatal dietary supplement

06

What researchers measure

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.

    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

  1. Incidence of Fetomaternal Complications

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

    Time frame: Throughout Pregnancy upto delivery

07

Study locations

1 site
  • Saira Memorial Hospital Model Town Lahore Pakistan
    Lahore, Punjab Province 54700, Pakistan
08

References and documents

Publications

  • 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).

Individual participant data

Plan to share: Undecided — It has not been determined whether individual participant data IPD will be shared. Any potential future sharing will depend on institutional review board IRB OR REC approval and participant privacy regulations.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2024 to primary completion in Jan 2025, 5 months.

Of 20 interventional studies with no phase under Hypocalcemia, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 39. This study's 5 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 25, 2026
First posted
Aug 7, 2026
StartActual
Aug 1, 2024
Primary completionActual
Jan 20, 2025
CompletionActual
Feb 14, 2025
Last update
Aug 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07751198
Lead sponsor
University of Lahore Hospital (ULH)
Responsible party
Wajeeha Sultana (Principal Investigator, University of Lahore Hospital (ULH)) — Principal investigator
First posted
Aug 7, 2026
Start date
Aug 1, 2024
Primary completion
Jan 20, 2025
Completion
Feb 14, 2025
Last update
Aug 12, 2026

Study contacts

HABIB UR REHMAN, PhD
principal investigator · NUR International University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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