Maternal Care PatternsVit-DNCT06562426
Relationship Between Maternal Awareness About Vitamin D for Under- Five Years Children and Their Health Status Outcomes
An observational study of Maternal Care Patterns and Child Nutrition Disorders, run by Alexandria University at 1 site in Egypt.
Trial summary
The observational study aims to identify the relationship between maternal awareness about vitamin D for under-five-year-old children and their health status outcomes. The research Question is : Is there a relationship between maternal awareness about vitamin D for under-five years children and their health status… Read more about this study
- Who is it for?
- Ages 1 year to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Maternal Care Patterns, Child Nutrition Disorders, Vitamin D Deficiency
- What is being tested?
- Descriptive group on vitamin D awareness
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Aug 2024to 28 Feb 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 1 year to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 300 mothers and their under-five years children will attend the out-patient clinics.
Who may be able to join
- under-five years
Who cannot join
- any associated neurological and chronic disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship Between Maternal Awareness About Vitamin D for Under- Five Years Children and Their Health Status Outcomes: Cross Sectional Study
The observational study aims to identify the relationship between maternal awareness about vitamin D for under-five-year-old children and their health status outcomes. The research Question is :
Is there a relationship between maternal awareness about vitamin D for under-five years children and their health status outcomes? Mothers of children under five will be interviewed about their knowledge and practices regarding vitamin D and their children's health status. Each child will be observed for the manifestation of vitamin D deficiency and to measure their weight and height.
Read the detailed description
The observational study aims to identify the relationship between maternal awareness about vitamin D for under-five-year-old children and their health status outcomes. The research Question is :
Is there a relationship between maternal awareness about vitamin D for under-five-year-old children and their health status outcomes? This study will be conducted in the Outpatient and Inpatient Departments of Smouha Children's University Hospital (SCUH) at Alexandria and Matrouh General Hospital and Specialized Children's Hospital at Matrouh City.
Mothers of children under five will be interviewed about their knowledge and practices regarding vitamin D and their children's health status. Each child will be observed for the manifestation of vitamin D deficiency and to measure their weight and height. Written informed consent for participation will be obtained from a under five years mothers after an explanation of the aim of the study, their voluntary participation, and the right to withdraw from the study at any time.
- Being tested
- Descriptive group on vitamin D awareness
- Keywords
- Vitamin D, Maternal Awareness, under-five children, Health status outcomes
- Medical subject headings
- Child Nutrition Disorders, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Descriptive group on vitamin D awarenessBehavioural
300 mothers of under-five children will be recruited in the descriptive study to assess their awareness about vitamin D and observe children for their health status outcome. Three tools will be used which are; sociodemographic characteristics of children and their mothers, Mothers' Awareness of Vitamin D Structured Interview Schedule, and Health Status Outcomes of Under- Five Years Children. Permission to conduct the study will be obtained from the administrative authorities of the settings after an explanation of the aim of the study. Each mother will be interviewed individually to obtain characteristics of mothers and their children, as well as knowledge and performance regarding Vitamin D. Each child will be observed for the manifestation of vitamin D deficiency and to measure their weight and height.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mothers' knowledge about Vitamin D Structured Interview Schedule to identify the mothers' knowledge regarding vitamin D supplementation.
It includes multiple questions about; the importance of vitamin D, different sources of vitamin D, the appropriate age for starting vitamin D supplementation, frequency of giving vitamin D, the proper dose of vitamin D, the method for exposing children to sun baths the food rich with vitamin D and the source of her knowledge about vitamin D.
All items will be scored at one point for known, and zero for unknown or incorrect answers. Mothers' responses for all knowledge items will be summed up and converted into percentages. All items will be scored at one point for known, and zero for unknown or incorrect answers. Mothers' responses for all knowledge items will be summed up and converted into percentages.
Mothers' awareness levels will be categorized as follows:
- Satisfied awareness level for ≥50%
- Unsatisfied awareness level <50%
Measured: through study completion, an average of 1 year.
Secondary outcomes (4)
Mothers' Performance About Vitamin D Supplementation Structured Interview Schedule to identify the mothers' performance regarding vitamin D supplementation.
It includes multiple questions about mothers' practices for giving vitamin D supplementation, exposing the child to sun and giving the child food rich in vitamin D . Responses will be scored as one point for correctly done and zero for not done. A total score of mother's performance will be summed up and converted into percentages. Mothers' performance level will be categorized as following:
- Satisfied performance level for ≥50%
- Unsatisfied performance level <50%
Measured: through study completion, an average of 1 year.
Manifestations of vitamin D deficiency assessment record. Each item will be scored with presence or absence.
It includes delayed closure of fontanels, delayed sitting and walking, delayed teething, muscles cramping, bow leg, knock knee and bone fracture.
Measured: through study completion, an average of 1 year.
Child's physical growth assessment sheet.
It includes weight/kg., length/ height/cm. and Body mass index/kg/m2.
Measured: through study completion, an average of 1 year.
Previous medical and surgical history sheet.
It includes items as exposure to any disease (pneumonia,...), previous hospitalization, cause of hospitalization, duration and previous surgery. Each item will be scored with No and Yes.
Measured: through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start10 Aug 2024
- Primary completion15 Aug 2024 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Maternal Care PatternsStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Badr, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06562426
- Sponsor's protocol ID
- MAVD
- Acronym
- Vit-D
- Status last verified
- Aug 2024
- First submitted
- 13 Aug 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Amaya-Montoya M, Duarte-Montero D, Nieves-Barreto LD, Montano-Rodriguez A, Betancourt-Villamizar EC, Salazar-Ocampo MP, Mendivil CO. 100 YEARS OF VITAMIN D: Dietary intake and main food sources of vitamin D and calcium in Colombian urban adults. Endocr Connect. 2021 Dec 9;10(12):1584-1593. doi: 10.1530/EC-21-0341.
PubMed 34766920Crincoli V, Cazzolla AP, Di Comite M, Lo Muzio L, Ciavarella D, Dioguardi M, Bizzoca ME, Palmieri G, Fontana A, Giustino A, Di Cosola M, Vincenzo B, Lovero R, Di Serio F. Evaluation of Vitamin D (25OHD), Bone Alkaline Phosphatase (BALP), Serum Calcium, Serum Phosphorus, Ionized Calcium in Patients with Mandibular Third Molar Impaction. An Observational Study. Nutrients. 2021 Jun 4;13(6):1938. doi: 10.3390/nu13061938.
PubMed 34200107Chang SW, Lee HC. Vitamin D and health - The missing vitamin in humans. Pediatr Neonatol. 2019 Jun;60(3):237-244. doi: 10.1016/j.pedneo.2019.04.007. Epub 2019 Apr 17.
PubMed 31101452Dinlen N, Zenciroglu A, Beken S, Dursun A, Dilli D, Okumus N. Association of vitamin D deficiency with acute lower respiratory tract infections in newborns. J Matern Fetal Neonatal Med. 2016 Mar;29(6):928-32. doi: 10.3109/14767058.2015.1023710. Epub 2015 Mar 19.
PubMed 25786473Luan Z, Ma Y, Xin Y, Qian J, Wang H. Possible Molecular Mechanisms by which Vitamin D Prevents Inflammatory Bowel Disease and Colitis-associated Colorectal Cancer. Curr Med Chem. 2017;24(9):911-917. doi: 10.2174/0929867323666161202153028.
PubMed 27915990Midtbo LK, Nygaard LB, Markhus MW, Kjellevold M, Lie O, Dahl L, Kvestad I, Froyland L, Graff IE, Oyen J. Vitamin D status in preschool children and its relations to vitamin D sources and body mass index-Fish Intervention Studies-KIDS (FINS-KIDS). Nutrition. 2020 Feb;70:110595. doi: 10.1016/j.nut.2019.110595. Epub 2019 Sep 19.
PubMed 31739173Nimitphong H, Park E, Lee MJ. Vitamin D regulation of adipogenesis and adipose tissue functions. Nutr Res Pract. 2020 Dec;14(6):553-567. doi: 10.4162/nrp.2020.14.6.553. Epub 2020 Aug 5.
PubMed 33282119
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Maternal Awareness About Vitamin D for Under- Five Years Children and Their Health Status Outcomes: Cross Sectional Study
- ClinicalTrials.gov ID
- NCT06562426
- Acronym / sponsor ID
- Vit-D / MAVD
- Keywords
- Vitamin D, Maternal Awareness, under-five children, Health status outcomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 10 Aug 2024 (actual)
- Primary completion
- 15 Aug 2024 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 20 Aug 2024 (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.
The observational study aims to identify the relationship between maternal awareness about vitamin D for under-five-year-old children and their health status outcomes. The research Question is :
Is there a relationship between maternal awareness about vitamin D for under-five years children and their health status outcomes? Mothers of children under five will be interviewed about their knowledge and practices regarding vitamin D and their children's health status. Each child will be observed for the manifestation of vitamin D deficiency and to measure their weight and height.
Detailed description
The observational study aims to identify the relationship between maternal awareness about vitamin D for under-five-year-old children and their health status outcomes. The research Question is :
Is there a relationship between maternal awareness about vitamin D for under-five-year-old children and their health status outcomes? This study will be conducted in the Outpatient and Inpatient Departments of Smouha Children's University Hospital (SCUH) at Alexandria and Matrouh General Hospital and Specialized Children's Hospital at Matrouh City.
Mothers of children under five will be interviewed about their knowledge and practices regarding vitamin D and their children's health status. Each child will be observed for the manifestation of vitamin D deficiency and to measure their weight and height. Written informed consent for participation will be obtained from a under five years mothers after an explanation of the aim of the study, their voluntary participation, and the right to withdraw from the study at any time.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 300 mothers and their under-five years children will attend the out-patient clinics.
Key inclusion criteria (1 listed)
- under-five years
Key exclusion criteria (1 listed)
- any associated neurological and chronic disorders
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 |
|---|---|---|
| Descriptive group on vitamin D awareness300 mothers of under-five children will be recruited in the descriptive study to assess their awareness about vitamin D and observe children for their health status outcome. Three tools will be used which are; sociodemographic characteristics of children and their mothers, Mothers' Awareness of Vitamin D Structured Interview Schedule, and Health Status Outcomes of Under- Five Years Children. Permission to conduct the study will be obtained from the administrative authorities of the settings after an explanation of the aim of the study. Each mother will be interviewed individually to obtain characteristics of mothers and their children, as well as knowledge and performance regarding Vitamin D. Each child will be observed for the manifestation of vitamin D deficiency and to measure their weight and height. | Behavioural | – |
Primary outcome
Mothers' knowledge about Vitamin D Structured Interview Schedule to identify the mothers' knowledge regarding vitamin D supplementation.
Time frame: through study completion, an average of 1 year.
It includes multiple questions about; the importance of vitamin D, different sources of vitamin D, the appropriate age for starting vitamin D supplementation, frequency of giving vitamin D, the proper dose of vitamin D, the method for exposing children to sun baths the food rich with vitamin D and the source of her knowledge about vitamin D. All items will be scored at one point for known, and zero for unknown or incorrect answers. Mothers' responses for all knowledge items will be summed up and converted into percentages. All items will be scored at one point for known, and zero for unknown or incorrect answers. Mothers' responses for all knowledge items will be summed up and converted into percentages. Mothers' awareness levels will be categorized as follows: * Satisfied awareness level for ≥50% * Unsatisfied awareness level <50%
4 secondary outcomes
Mothers' Performance About Vitamin D Supplementation Structured Interview Schedule to identify the mothers' performance regarding vitamin D supplementation.
Time frame: through study completion, an average of 1 year.
Manifestations of vitamin D deficiency assessment record. Each item will be scored with presence or absence.
Time frame: through study completion, an average of 1 year.
Child's physical growth assessment sheet.
Time frame: through study completion, an average of 1 year.
Previous medical and surgical history sheet.
Time frame: through study completion, an average of 1 year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Background: PubMed 34766920Amaya-Montoya M, Duarte-Montero D, Nieves-Barreto LD, Montano-Rodriguez A, Betancourt-Villamizar EC, Salazar-Ocampo MP, Mendivil CO. 100 YEARS OF VITAMIN D: Dietary intake and main food sources of vitamin D and calcium in Colombian urban adults. Endocr Connect. 2021 Dec 9;10(12):1584-1593. doi: 10.1530/EC-21-0341.
- Background: PubMed 34200107Crincoli V, Cazzolla AP, Di Comite M, Lo Muzio L, Ciavarella D, Dioguardi M, Bizzoca ME, Palmieri G, Fontana A, Giustino A, Di Cosola M, Vincenzo B, Lovero R, Di Serio F. Evaluation of Vitamin D (25OHD), Bone Alkaline Phosphatase (BALP), Serum Calcium, Serum Phosphorus, Ionized Calcium in Patients with Mandibular Third Molar Impaction. An Observational Study. Nutrients. 2021 Jun 4;13(6):1938. doi: 10.3390/nu13061938.
- Background: PubMed 31101452Chang SW, Lee HC. Vitamin D and health - The missing vitamin in humans. Pediatr Neonatol. 2019 Jun;60(3):237-244. doi: 10.1016/j.pedneo.2019.04.007. Epub 2019 Apr 17.
- Background: PubMed 25786473Dinlen N, Zenciroglu A, Beken S, Dursun A, Dilli D, Okumus N. Association of vitamin D deficiency with acute lower respiratory tract infections in newborns. J Matern Fetal Neonatal Med. 2016 Mar;29(6):928-32. doi: 10.3109/14767058.2015.1023710. Epub 2015 Mar 19.
- Background: PubMed 27915990Luan Z, Ma Y, Xin Y, Qian J, Wang H. Possible Molecular Mechanisms by which Vitamin D Prevents Inflammatory Bowel Disease and Colitis-associated Colorectal Cancer. Curr Med Chem. 2017;24(9):911-917. doi: 10.2174/0929867323666161202153028.
- Background: PubMed 31739173Midtbo LK, Nygaard LB, Markhus MW, Kjellevold M, Lie O, Dahl L, Kvestad I, Froyland L, Graff IE, Oyen J. Vitamin D status in preschool children and its relations to vitamin D sources and body mass index-Fish Intervention Studies-KIDS (FINS-KIDS). Nutrition. 2020 Feb;70:110595. doi: 10.1016/j.nut.2019.110595. Epub 2019 Sep 19.
- Background: PubMed 33282119Nimitphong H, Park E, Lee MJ. Vitamin D regulation of adipogenesis and adipose tissue functions. Nutr Res Pract. 2020 Dec;14(6):553-567. doi: 10.4162/nrp.2020.14.6.553. Epub 2020 Aug 5.
- Individual participant dataSharing planned: Undecided
Related trials for Maternal Care Patterns
Active, not recruiting
Melanated Group Midwifery Care (MGMC)
Pregnancy Complications, Maternal Care Patterns
Active, not recruiting
An Adjunctive Neurofeedback Training Program to Enhance Wellness Among Trauma-Exposed Postpartum Mothers
Well-Being, Psychological, Dissociation
Active, not recruiting
An Intervention to Enhance Well-Being in Trauma Exposed New Mothers
Post-traumatic Stress Disorder, Dissociation
Active, not recruiting
Pivotal, Prospective, Multi-centre, Single-arm Study to Evaluate the Safety and Effectiveness of Oli for Identification of Patients, During the Intrapartum Period, Who Are at Higher Risk of Developing Abnormal Postpartum Uterine Bleeding, Including Postpartum Haemorrhage
Post Partum Haemorrhage, Maternal Care Patterns
Active, not recruitingObservational study
Utilization of Maternal Healthcare Services and Infant Feeding Practices
Maternal Health, Prenatal Care
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Maternal Care Patterns and Child Nutrition Disorders, run by Alexandria University at 1 site in Egypt.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 20 Aug 2024. 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 Egypt. 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?
Results are not available in the source record.
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?
Mothers' knowledge about Vitamin D Structured Interview Schedule to identify the mothers' knowledge regarding vitamin D supplementation. (time frame: through study completion, an average of 1 year.). 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 NCT06562426, which also lists 7 linked publications.
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 20 Aug 2024.