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Efficacy of Chromium Picolinate in Reducing Acanthosis Nigricans Severity in Adolescents With Insulin Resistance

NCT07371169 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-02-23

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if chromium picolinate can reduce the severity of acanthosis nigricans and improve insulin resistance in adolescents with both conditions. It will also learn about the safety of chromium picolinate use in this age group. The main questions it aims to answer are:

1. Does chromium picolinate reduce the severity of acanthosis nigricans as measured by the Burke quantitative scale for acanthosis nigricans severity in adolescents with insulin resistance?
2. Does chromium picolinate improve insulin resistance as measured by the homeostasis model assessment of insulin resistance (HOMA-IR)?
3. What medical problems do participants have when taking chromium picolinate? Researchers will compare chromium picolinate to placebo to see if chromium picolinate is effective in reducing acanthosis nigricans severity and improving insulin resistance.

Participants will:

1. Take chromium picolinate or placebo daily for 24 weeks.
2. Acquire baseline assessment and then visit the clinic at 8 weeks, 16 weeks, and 24 weeks for clinical evaluation, acanthosis nigricans severity assessment using the Burke quantitative scale for acanthosis nigricans severity, laboratory assessment of insulin resistance using the homeostasis model assessment of insulin resistance, and monitoring for any side effects or complications.

Conditions

Interventions

DRUG

Chromium picolinate

Chromium Picolinate Cap. 200mcg once daily for 24-weeks.

DRUG

Placebo matching Chromium Picolinate

An inert capsule identical in appearance and packaging to the chromium picolinate 200 microgram capsule (same size, shape, color, weight, and dosing schedule), manufactured without active ingredient. The capsule shell is composed of gelatin or hypromellose, matching the active capsules. The capsule is filled with inert excipients suitable for oral capsules, such as microcrystalline cellulose and magnesium stearate, to replicate the weight and flow properties of the active capsules. Optional coloring agents are included as needed to match the active product. Capsules are packaged in sealed blisters to minimize odor, taste, and visual cues. Dispensed by the investigational pharmacy according to the randomization schedule; to be taken once daily.

Sponsors & Collaborators

  • Uruk University

    lead OTHER

Principal Investigators

  • Ghasak Kais Abdulhussain, BSc, MSc, PhD (Pharmacology) · Uruk University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2026-01-01
Completion
2026-01-01

Countries

  • Iraq

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07371169 on ClinicalTrials.gov