Evaluation of the effect of arginine administration on height growth of Children in lower limit range

Investigating the effect of arginine administration on the linear growth of prepubescent children with low-normal stature over a one-year period at Bu Ali Children's Hospital in Ardabil

A single-blind clinical trial will be conducted at Boali Children's Hospital in Ardabil in 1401 with a sample size of 76 children (38 males, 38 females) above age 5, selected randomly from the medical clinics of the University of Medical Sciences in Ardabil. Their group assignment was determined using identical packets.

This randomized controlled trial was conducted at the Bu Ali Children's Hospital in Ardabil. Children were systematically divided into control and treatment groups. The study maintained a double-blind approach where neither the participants nor the investigators were aware of the supplement (arginine or placebo) given to the children.

The study will involve 76 prepubescent children, including 38 boys and 38 girls, who fall under the lower limit of normal height (3rd and 10th percentiles). Inclusion criteria: Prepubescent children who are healthy but fall under the lower limit of normal height.Exclusion criteria: Any individual requiring growth hormone therapy or experiencing severe side effects from arginine will be excluded from the study.

Control group: Will receive daily Vitamin D supplement at a dosage of 1,000 IU and a placebo capsule resembling the arginine capsule used in the study. Treatment group: Along with a daily Vitamin D supplement at a dosage of 1,000 IU, will also receive 250 mg of arginine per day.

Height increment; Weight gain; Rate of linear growth.

Randomization Method and Explanation for Each: Simple randomization has been utilized. In this method, each participant is randomly allocated to either the control or intervention group. Unit of Randomization: Individual-level randomization. Stratification Layers: Gender stratification has been implemented, ensuring that for every male child selected, a female child is included, and vice versa. Randomization Tool: Similar packets indicating Group A (control) or Group B (intervention). Procedure for Creating a Random Sequence: The sample size has been determined using the G-POWER software. Once participants are selected, a random sequence for entry into groups is established. Explanation on Allocation Concealment: Participants are assigned to various groups using indistinguishable packets, unaware of their contents. Consequently, participants remain blinded to their group assignments.

To keep participants unaware of which group they belong to, similar packets will be prepared. Participants will randomly pick one of these packets, which will indicate whether they are in Group A (control) or Group B (intervention), but they will not be told the type of intervention being applied in their group. This ensures a single-blind study design.

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