AzTrials
AzTrials

Bone LossNCT06135441

Bone Manifestation of Nutritional Disorders Among Infants and Pre-school Children

An observational study of Bone Loss and Nutrition Disorders, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Nutrients important to bones. Because bones undergo continuous remodeling, an adequate supply of nutrient substrate is needed to support the formation phase of bone remodeling. In addition to their passive roles as substrate for bone formation, dietary calcium and protein play active roles in bone metabolism, as well… Read more about this study

Who is it for?
Ages 1 month to 18 years
Conditions the study is for
Bone Loss, Nutrition Disorders
How many people
60 participants
Where
No sites listed yet
Study dates
1 Dec 2023to 1 Nov 2024
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 month to 18 years
  • All sexes
  • Child, Adult

Study population: Children from month till age of 18 years attending to Assiut university children hospital's metabolic, nutrition and orthopedic clinics with short statue, bone deformity or anomaly.

Who may be able to join

  • All malnutrition cases attending the nutrition out-patient clinic in AUH

Who cannot join

  • bone disorders in non-malnourished cases
  • bone disease due to a genetic disorder

About this study

Official title: Bone Manifestation of Nutritional Disorders Among Infants and Pre-school Children Attending Assiut University Children Hospital

Nutrients important to bones. Because bones undergo continuous remodeling, an adequate supply of nutrient substrate is needed to support the formation phase of bone remodeling. In addition to their passive roles as substrate for bone formation, dietary calcium and protein play active roles in bone metabolism, as well as phosphorus and vitamin D. Other vitamins and minerals are also needed for metabolic processes related to bone, directly or indirectly.

Read the detailed description

Nutrients important to bones. Because bones undergo continuous remodeling, an adequate supply of nutrient substrate is needed to support the formation phase of bone remodeling. In addition to their passive roles as substrate for bone formation, dietary calcium and protein play active roles in bone metabolism, as well as phosphorus and vitamin D. Other vitamins and minerals are also needed for metabolic processes related to bone, directly or indirectly.

The Food and Nutrition Board (FNB) of the National Academy of Sciences, has released in the past few years the new Dietary Reference Intakes (DRI) based on the latest understanding about nutrient requirements for optimizing health.

The fetal period, early life, childhood, and puberty are critical periods for the development and/or programming of metabolic systems, including the skeleton. Osteoporosis is described by the World Health Organization (WHO) as a progressive systemic skeletal disease characterized by low bone mass and microarchitectural deterioration of bone tissue, with a consequent increase in bone fragility and susceptibility to fracture. Because of the morbidity of osteoporosis, the prevention of this disease and its associated fractures is considered essential to the maintenance of health, quality of life, and independence in the elderly population.

Peak bone mass attained during childhood and adolescence determines skeletal fragility in old age.

Peak bone mass is the amount of bone acquired when accrual ceases or reaches a plateau at some point after the completion of growth and development. Metabolic bone disease (MBD) is an umbrella term that encompasses a broad spectrum of clinically different diseases that share the common finding of an aberrant bone chemical milieu leading to a defective skeleton and bone abnormalities. Metabolic bone diseases are usually characterized by a dramatic clinical presentation and manifestation that are commonly reversible once the underlying defect has been treated. Abnormalities of minerals include calcium, phosphorus, magnesium, or vitamin D developing as a result of dysfunctions of the various factors that control mineral homeostasis. The defective mineralization translates into rickets at the level of the epiphyseal growth plates and osteomalacia on the endocortical and cancellous bone surfaces Moreover, osteogenesis imperfecta (OI) pathogenesis has been expanded from a simple collagen defect to abnormalities in bone cell metabolism and development with primary defects in osteoblast differentiation. Metabolic bone disease is to be differentiated from skeletal dysplasia which are a larger group of genetic bone disorders that overlaps with MBD. In contrast to MBD, skeletal dysplasias are heritable diseases that have generalized abnormalities in cartilage and bone. The primary defects are in specific signal system or cell types that orchestrate processes of skeleton formation causing the bone disorder.

Medical subject headings
Bone Diseases, Metabolic, Nutrition Disorders

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence of bone affection by nutritional disorders in Assiut University Hospital.

    The prevalence of bone affection by nutritional disorders in Assiut University Hospital.

    Measured: Baseline

  2. Different manifestations of bone affection by nutritional disorders

    Different manifestations of bone affection by nutritional disorders

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2023
  2. Study start1 Dec 2023 (estimated)
  3. Primary completion1 Jun 2024 (estimated)
  4. Study completion1 Nov 2024 (estimated)

Resources

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
Other
Time perspective
Prospective
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06135441
Sponsor's protocol ID
Bone manifestation
Status last verified
Nov 2023
First submitted
13 Nov 2023
Last updated
18 Nov 2023
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Bone Loss and Nutrition Disorders, run by Assiut University.

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 2 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 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

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?

Prevalence of bone affection by nutritional disorders in Assiut University Hospital. (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 18 Nov 2023.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in