Vitamin D Supplementation and Glycemic Control Improvement Among Type 1 Diabetic Children

Summary

Type 1 diabetes mellitus (T1DM) is an immune-mediated disease characterized by diminished insulin secretion due to damage to islets of Langerhans in the pancreas, which eventually results in high levels of glucose in the blood. According to World Diabetes Foundation, in Palestine, 4.4% of diabetic patients are diagnosed with T1DM, while 95.3% are diagnosed with type 2 diabetes (T2DM) (World Diabetes Foundation, 2020).

Observational studies have reliably provided evidence that T1DM patients with acceptable glycemic control have higher 25(OH)D levels than T1DM with lesser glycemic control. Additionally, it has been specified by some of the research-based studies that there is a strong connection between the deficiency of vitamin D and the incidence of T1DM.

In interventional studies of T1DM children and adults, repletion of vitamin D in deficient individuals improved HbA1c in a period of 12 weeks. Participants were more likely to achieve HbA1c \< 7.8% if they had higher 25(OH)D levels on week 12 than on baseline, especially if 25(OH)D levels were exceeded 51 nmol/l.

According to the Food and Drug Administration (FDA), The Institute of Medicine's (IOM) recommended Upper Limit (UL) for chronic Vitamin D intake for infants (children less than 1 year of age) is 25 mcg/day (1,000 IU/d), and for children age 1 year and older the recommended UL is 50 mcg/day (2,000 IU/d) (Institute of Medicine Standing Committee on the Scientific Evaluation of Dietary Reference Intakes, 1997).

Despite a large amount of evidence from observational and experimental studies supporting the effects of vitamin D on glucose metabolism and the immune system, results from clinical studies remain inconsistent, which makes it impossible to recommend vitamin D supplementation for the treatment of T1DM. Therefore, this study aimed to investigate the status of vitamin D among T1DM children for vitamin and to examine the effects of vitamin D supplementation on glycemic control in children with T1DM. This is the first randomized controlled trial that studied the effects of vitamin D supplementation on glycemic control among T1DM children in the Gaza Strip, Palestine.

Conditions

• Type 1 Diabetes Mellitus
• Vitamin D Deficiency

Interventions

DIETARY_SUPPLEMENT

vitamin D supplements (2000 IU/day)

The interventional (experimental) group received vitamin D supplements (2000 IU/day). According to previous studies and after the direct supervision from the treating pediatrician and endocrinologist, the best preparation and dosage of vitamin D was used (According to FDA the recommended dose for children age 1 year and older is 2,000 IU/day).

Sponsors & Collaborators

• Al-Azhar University

  lead OTHER

Principal Investigators

• Heba A Al Sarraj, PhD · Department of Laboratory Medicine, Al Azhar University-Gaza, Gaza Strip, Palestine

• Ashraf J Shaqaliah, Master · Department of Laboratory Medicine, Al Azhar University-Gaza, Gaza Strip, Palestine

• Heba M Arafat, PhD · Department of Chemical Pathology, School of Medical Sciences, Universiti Sains Malaysia

• Ohood M Shamallakh, Master · Department of a Medical Laboratory Sciences, Faculty of Health Sciences, Islamic University of Gaza

• Kholoud M Shamallakh, Master · Department of a Medical Laboratory Sciences, Faculty of Health Sciences, Islamic University of Gaza

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

4 Years

Max Age

14 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-10-01

Primary Completion

2018-01-01

Completion

2021-06-16

Countries

• Palestinian Territories

Study Locations