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Type 1 Diabetes MellitusNCT05141968

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

A study testing vitamin D supplements (2000 IU/day) in people with Type 1 Diabetes Mellitus and Vitamin D Deficiency, run by Al-Azhar University at 1 site in Palestinian Territories.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 4 to 14 years
What is being tested?
vitamin D supplements (2000 IU/day)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 sitePalestinian Territories
Study dates
1 Oct 2017to 16 Jun 2021
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 4 to 14 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Children (4-14 years of age) of both genders, with a T1DM.
  • Not on vitamin D Supplementation. Exclusion criteria for children with T1DM
  • Age ≤ 4 or more than14 years old
  • Patients with T2DM
  • Children had received vitamin D supplements

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Palestinian Territories1 site

  • Al-Rantisi pediatric hospital

    Gaza, 79702

Other trials in Palestinian Territories

About this study

Official title: The Effects of Vitamin D Supplementation on Glycemic Control in Children With Type 1 Diabetes Mellitus in Gaza Strip, A Randomized Controlled Trial

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.

Read more

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.

Read the detailed description

2.1 Study design The study design was experimental, A randomized controlled trial. 2.2 Study setting The study was conducted at the endocrinology outpatients' clinic at AL-RANTISI PEDIATRIC HOSPITAL in Gaza Strip.

2.3 Study Sample After getting the ethical approval, data were collected throughout 3 months, starting from October 2017 to January 2018. In this period, 80 children who were less than 14 years old were diagnosed with T1DM which was indicated through fasting blood glucose level greater than 126 mg/dl or HbA1c cut point of ≥6.5% (American Diabetes Association, 2010), and had vitamin D deficiency which indicated by its levels of less than 12 ng/ml (Sullivan, 2019), were recruited from endocrinology outpatients' clinic at AL-RANTISI PEDIATRIC HOSPITAL in Gaza Strip.

2.4 Sampling

A stratified random sampling technique was applied to assign children with the previously mentioned criteria into two groups. The first group is the interventional (experimental) group that received vitamin D supplements (2000 IU/day) and the second group is the control group that did not receive any supplements. Both groups were on their regular diet and treatment, but one group was put on vitamin D supplement and the other group received a placebo instead. 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). The two groups were defined as follows:

Group A: is the control group, that received a placebo as a supplement. Group B: is the interventional group that supplemented with vitamin D tablets containing 2000 IU once time daily with a meal, for 3 months of intervention.

Concerning the laboratory investigations; vitamin D status was assessed by measuring the concentration of 25-hydroxyvitamin D (25(OH)D) in the children's serum. Levels of 25(OH)D were interpreted as deficiency (≤20 ng/ml or ≤50 nmol/L), insufficiency (21-29 ng/ml or 52.5-72.5 nmol/L), and sufficiency (30-100 ng/ml ng/ml or 75-250 nmol/L). The glycated hemoglobin levels are defined based on the control of diabetes, as good control (HbA1c<7.8%), moderate control (HbA1c:7.8%-9.9%), and poor control (HbA1c>9.9%).

2.5 Tools of Data Collection

Children's health assessment structure interview sheet was used to collect data. It was constructed by the researchers based upon relevant literature. The questionnaire consisted of three parts:

Part I: Children's socio-demographic characteristics This part was aimed to collect socio-demographic characteristics for both interventions, and control groups before the intervention such as age, gender, number of family members, and level of education.

Part II: Children's current health history It covered the history of the discovery of diabetes, duration of diabetes, type of insulin, family history of diabetes, and periodic test for diabetes. This part had been used before the intervention for both the intervention and control groups.

Part III: Children's laboratory investigations This part addressed HbA1c that was investigated and recorded before and after the interference for both interventions, and control groups. Additionally, vitamin D status was assessed and recorded before the intervention for both interventions, and control groups.

2.6 Statistical analysis Data was entered and statistically analyzed using a statistical package for social sciences (SPSS) version 26 database for windows 10. Descriptive statistics were used to summarize the socio-demographic characteristics of subjects. Numerical data like 25-(OH)D levels, and HbA1c, were presented as mean (SD) or median (IQR) based on their normality distribution. Categorical data were presented as frequency (percentage). The chi-square test was used for categorical data comparison. Analysis of quantitative data between two groups was done using unpaired t-test. Pearson correlation coefficients between continuous variables were used as a measure of association. A p-value <0.05 was considered statistically significant.

Being tested
vitamin D supplements (2000 IU/day)
Keywords
Vitamin D Supplementation, Glycemic Control, Type 1 Diabetes Mellitus, Gaza Strip, Randomized Controlled Trial.
Medical subject headings
Diabetes Mellitus, Type 1, Vitamin D Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • vitamin D supplements (2000 IU/day)Dietary supplement

    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).

Study groups in NCT05141968
Study groupRoleWhat they receive
Vitamin D supplements groupExperimentalGroup A: is the interventional group that supplemented with vitamin D tablets contain 2000 IU once time daily with a meal, for 3 months of intervention.
Receives: Dietary Supplement: vitamin D supplements (2000 IU/day)
Control groupNo interventionGroup B: is the control group, that did not receive any supplements.

What is being measured

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

  1. Percent of HbA1c in children with T1DM for both intervention, and control groups.

    Change of glycemic control in children with T1DM. The glycohemoglobin levels are defined based on the control of diabetes, as good control (HbA1c<7.8%), moderate control (HbA1c:7.8%-9.9%), and poor control (HbA1c>9.9%). The percent of HbA1c was measured and recorded before and after the interference for both interventions, and control groups, (the interventional group was supplemented with vitamin D tablets containing 2000 IU once time daily with a meal, for 3 months of intervention).

    Children's health assessment structure interview sheet was used to collect data. It was constructed by the researchers based upon relevant literature. The questionnaire consisted of three parts Part I: Children's socio-demographic characteristics Part II: Children's current health history Part III: Children's laboratory investigations

    Measured: Three Months

Secondary outcomes (1)

  1. Concentration of Vitamin D for both intervention, and control groups

    Screening for vitamin D deficiency among type 1 diabetic children. The vitamin D status was assessed by measuring the concentration of 25-hydroxyvitamin D (25(OH)D) in the children's serum. Levels of 25(OH)D were interpreted as deficiency (≤20 ng/ml or ≤50 nmol/L), insufficiency (21-29 ng/ml or 52.5-72.5 nmol/L), and sufficiency (30-100 ng/ml ng/ml or 75-250 nmol/L). Vitamin D status was assessed and recorded before and after the intervention for both interventions, and control groups.

    Measured: Three Months

Timeline

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

  1. First posted2 Dec 2021
  2. Study start1 Oct 2017
  3. Primary completion1 Jan 2018
  4. Study completion16 Jun 2021

Resources

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
Screening
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05141968
Sponsor's protocol ID
AlAzharDiabetes
Status last verified
Nov 2021
First submitted
30 Oct 2021
Last updated
2 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Al-Agha, A. E., & Ahmad, I. A. (2015). Association among vitamin D deficiency, type 1 diabetes mellitus, and glycemic control. J Diabetes Metab, 6(594), 2.

  • Aljabri KS, Bokhari SA, Khan MJ. Glycemic changes after vitamin D supplementation in patients with type 1 diabetes mellitus and vitamin D deficiency. Ann Saudi Med. 2010 Nov-Dec;30(6):454-8. doi: 10.4103/0256-4947.72265.

    PubMed 21060157

  • American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2010 Jan;33 Suppl 1(Suppl 1):S62-9. doi: 10.2337/dc10-S062. No abstract available.

    PubMed 20042775

  • Bizzarri C, Pitocco D, Napoli N, Di Stasio E, Maggi D, Manfrini S, Suraci C, Cavallo MG, Cappa M, Ghirlanda G, Pozzilli P; IMDIAB Group. No protective effect of calcitriol on beta-cell function in recent-onset type 1 diabetes: the IMDIAB XIII trial. Diabetes Care. 2010 Sep;33(9):1962-3. doi: 10.2337/dc10-0814.

    PubMed 20805274

  • Busta, A., Alfonso, B., & Poretsky, L. (2011). Role of vitamin D in the pathogenesis and therapy of type 1 diabetes mellitus. In Type 1 diabetes-complications, pathogenesis, and alternative treatments (pp. 95-118): Intech, Rijeka.

  • El-Sayed, R. E.-S. H., Abd El Raaouf, S. E. H., & Laimon, W. (2019). Effect of Vitamin D Supplementation on Glycemic Control in Children with Type 1 Diabetes Mellitus: A Randomized Clinical Trial. American Journal of Nursing, 7(4), 534-541.

  • Elhamalawi, I. M. F. (2015). Assessment of serum Vitamin D in Type 1 Diabetic Patients from Gaza Strip.

  • Gabbay MA, Sato MN, Finazzo C, Duarte AJ, Dib SA. Effect of cholecalciferol as adjunctive therapy with insulin on protective immunologic profile and decline of residual beta-cell function in new-onset type 1 diabetes mellitus. Arch Pediatr Adolesc Med. 2012 Jul 1;166(7):601-7. doi: 10.1001/archpediatrics.2012.164.

    PubMed 22751874

  • George PS, Pearson ER, Witham MD. Effect of vitamin D supplementation on glycaemic control and insulin resistance: a systematic review and meta-analysis. Diabet Med. 2012 Aug;29(8):e142-50. doi: 10.1111/j.1464-5491.2012.03672.x.

    PubMed 22486204

  • Griz LH, Bandeira F, Gabbay MA, Dib SA, Carvalho EF. Vitamin D and diabetes mellitus: an update 2013. Arq Bras Endocrinol Metabol. 2014 Feb;58(1):1-8. doi: 10.1590/0004-2730000002535.

    PubMed 24728158

  • Hafez M, Hassan M, Musa N, Abdel Atty S, Azim SA. Vitamin D status in Egyptian children with type 1 diabetes and the role of vitamin D replacement in glycemic control. J Pediatr Endocrinol Metab. 2017 Apr 1;30(4):389-394. doi: 10.1515/jpem-2016-0292.

    PubMed 27997353

  • Holick MF, Binkley NC, Bischoff-Ferrari HA, Gordon CM, Hanley DA, Heaney RP, Murad MH, Weaver CM; Endocrine Society. Evaluation, treatment, and prevention of vitamin D deficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2011 Jul;96(7):1911-30. doi: 10.1210/jc.2011-0385. Epub 2011 Jun 6.

    PubMed 21646368

  • nstitute of Medicine Standing Committee on the Scientific Evaluation of Dietary Reference Intakes. (1997). Dietary reference intakes for calcium, phosphorus, magnesium, vitamin D, and fluoride.

  • Katsarou A, Gudbjornsdottir S, Rawshani A, Dabelea D, Bonifacio E, Anderson BJ, Jacobsen LM, Schatz DA, Lernmark A. Type 1 diabetes mellitus. Nat Rev Dis Primers. 2017 Mar 30;3:17016. doi: 10.1038/nrdp.2017.16.

    PubMed 28358037

  • Lamichhane AP, Crandell JL, Jaacks LM, Couch SC, Lawrence JM, Mayer-Davis EJ. Longitudinal associations of nutritional factors with glycated hemoglobin in youth with type 1 diabetes: the SEARCH Nutrition Ancillary Study. Am J Clin Nutr. 2015 Jun;101(6):1278-85. doi: 10.3945/ajcn.114.103747. Epub 2015 May 6.

    PubMed 25948670

Questions about this trial

What is this clinical trial studying?

A study testing vitamin D supplements (2000 IU/day) in people with Type 1 Diabetes Mellitus and Vitamin D Deficiency, run by Al-Azhar University at 1 site in Palestinian Territories.

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 5 inclusion and 0 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 2 Dec 2021. 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 Palestinian Territories. 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?

Percent of HbA1c in children with T1DM for both intervention, and control groups. (time frame: Three Months). 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 NCT05141968, which also lists 24 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 2 Dec 2021.

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