HypocalcemiaNCT07751198
Therapeutic Effects of Oat-based Cereal on Fetomaternal Outcomes Among Hypocalcemic Antenatal Women
A study testing Oat-Based porridge and Calcium & Vitamin D3 supplementation in people with Hypocalcemia and Pregnancy Complications Affecting Fetus (Diagnosis), run by University of Lahore Hospital (ULH) at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Hypocalcemia, Pregnancy Complications Affecting Fetus (Diagnosis)
- What is being tested?
- Oat-Based porridge and Calcium & Vitamin D3 supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2024to 14 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Saira Memorial Hospital Model Town Lahore Pakistan
Lahore, Punjab Province, 54700
About this study
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.
- Being tested
- Oat-Based porridge, Calcium & Vitamin D3 supplementation
- Keywords
- Hypocalcemia, Feto-maternal outcomes, Oat-based Porridge, Pregnancy nutrition,, Calcium and vit D supplementation, Maternal health
- Medical subject headings
- Hypocalcemia, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oat-Based porridgeDietary supplement
participants consumed Oat-based porridge daily as part of their diet during pregnancy alongside standard prenatal supplements
Calcium & Vitamin D3 supplementationDietary supplement
Also called prenatal dietary supplement
standard prescribed by physicians
| Study group | Role | What they receive |
|---|---|---|
| CONTROL GROUP | Active comparator | Participants receiving standard supplementation of calcium and vit.D Receives: Dietary Supplement: Calcium & Vitamin D3 supplementation |
| EXPERIMENTAL GROUP | Experimental | Participants receiving standard supplementation of calcium and vit.D along with interventional Oat-Based Porridge Receives: Dietary Supplement: Oat-Based porridge; Dietary Supplement: Calcium & Vitamin D3 supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: .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
Measured: Throughout Pregnancy upto delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start1 Aug 2024
- Primary completion20 Jan 2025
- Study completion14 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypocalcemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore Hospital (ULH)
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Wajeeha Sultana, University of Lahore Hospital (ULH)
- Investigators
- HABIB UR REHMAN, PhD, Principal investigator, NUR International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07751198
- Sponsor's protocol ID
- 518/24
- Other IDs
- 518/24
- Status last verified
- Aug 2026
- First submitted
- 25 Jul 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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).
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effects of Oat-based Cereal on Fetomaternal Outcomes Among Hypocalcemic Antenatal Women
- ClinicalTrials.gov ID
- NCT07751198
- Acronym / sponsor ID
- 518/24
- Keywords
- Hypocalcemia, Feto-maternal outcomes, Oat-based Porridge, Pregnancy nutrition,, Calcium and vit D supplementation, Maternal health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- University of Lahore Hospital (ULH)Research network
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 20 Jan 2025 (actual)
- Study completion
- 14 Feb 2025 (actual)
- First posted
- 7 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| CONTROL GROUP | Active comparator | Dietary Supplement: Calcium & Vitamin D3 supplementationParticipants receiving standard supplementation of calcium and vit.D |
| EXPERIMENTAL GROUP | Experimental | Dietary Supplement: Oat-Based porridge, Dietary Supplement: Calcium & Vitamin D3 supplementationParticipants receiving standard supplementation of calcium and vit.D along with interventional Oat-Based Porridge |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oat-Based porridgeparticipants consumed Oat-based porridge daily as part of their diet during pregnancy alongside standard prenatal supplements | Dietary supplement | EXPERIMENTAL GROUP |
| Calcium & Vitamin D3 supplementationAlso: prenatal dietary supplementstandard prescribed by physicians | Dietary supplement | CONTROL GROUP, EXPERIMENTAL GROUP |
Primary outcome
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.
1 secondary outcome
Incidence of Fetomaternal Complications
Time frame: Throughout Pregnancy upto delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- BackgroundArshad, 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 dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
HABIB UR REHMAN, PhD principal investigator
NUR International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oat-Based porridge and Calcium & Vitamin D3 supplementation in people with Hypocalcemia and Pregnancy Complications Affecting Fetus (Diagnosis), run by University of Lahore Hospital (ULH) at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 .). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07751198, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.