NCT06562426

Brief 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 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 10, 2024

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2024

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 20, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

August 20, 2024

Status Verified

August 1, 2024

Enrollment Period

5 days

First QC Date

August 13, 2024

Last Update Submit

August 18, 2024

Conditions

Keywords

Vitamin DMaternal Awarenessunder-five childrenHealth status outcomes

Outcome Measures

Primary Outcomes (1)

  • 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%

    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.

    through study completion, an average of 1 year.

  • Manifestations of vitamin D deficiency assessment record. Each item will be scored with presence or absence.

    through study completion, an average of 1 year.

  • Child's physical growth assessment sheet.

    through study completion, an average of 1 year.

  • Previous medical and surgical history sheet.

    through study completion, an average of 1 year.

Interventions

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.

Eligibility Criteria

Age1 Year - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

300 mothers and their under-five years children will attend the out-patient clinics.

You may qualify if:

  • under-five years

You may not qualify if:

  • any associated neurological and chronic disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eman Arafa Badr

Alexandria, 21533, Egypt

Location

Related Publications (7)

  • 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.

    PMID: 34766920BACKGROUND
  • Crincoli 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.

    PMID: 34200107BACKGROUND
  • Chang 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.

    PMID: 31101452BACKGROUND
  • Dinlen 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.

    PMID: 25786473BACKGROUND
  • Luan 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.

    PMID: 27915990BACKGROUND
  • Midtbo 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.

    PMID: 31739173BACKGROUND
  • Nimitphong 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.

    PMID: 33282119BACKGROUND

MeSH Terms

Conditions

Child Nutrition DisordersVitamin D Deficiency

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesAvitaminosisDeficiency DiseasesMalnutrition

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 13, 2024

First Posted

August 20, 2024

Study Start

August 10, 2024

Primary Completion

August 15, 2024

Study Completion

February 28, 2025

Last Updated

August 20, 2024

Record last verified: 2024-08

Locations